ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System

Not Applicable

Completed

• Conditions: Atherosclerosis; Peripheral Vascular Disease; Claudication
• Interventions: Device: ESPRIT BVS

• Registration Number: NCT01468974
• Lead Sponsor: Abbott Medical Devices

Brief Summary

The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-02
• Study First Submitted QC: 2011-11-08
• Study First Posted: 2011-11-10
• Primary Completion: 2015-08
• Study Completion: 2015-12
• Status Verified: 2018-02
• Results First Submitted: 2018-02-06
• Results First Submitted QC: 2018-09-04
• Last Update Submitted: 2018-09-04
• Results First Posted: 2019-02-04
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Subject is ≥ 18 and ≤ 80 years of age at the time of signing informed consent.

2. Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 1-3).

   For subjects with bilateral lesions, the higher Rutherford-Becker Clinical Category limb will be considered the target extremity to be treated in this trial.

   If both limbs are of the same Rutherford Becker Clinical Category, the target extremity will be selected based on investigator discretion.

3. Subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and is able to provide informed consent.

4. Subject agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.

5. Female subject of childbearing potential must: have had a negative pregnancy test within 14 days before treatment; not be nursing at the time of the study procedure and agree at time of consent to use birth control during participation in this trial.

6. Subject has life expectancy > 12 months.

7. Subject is able to take clopidogrel or prasugrel (or ticlopidine, if the subject cannot take clopidogrel or prasugrel) and acetylsalicylic acid (aspirin).

8. Subject must agree not to participate in any other clinical investigation for a period of 12 months following the index procedure. This includes clinical trials of medications and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.

Angiographic Inclusion Criteria

1. A single de novo native disease segment of the superficial femoral (SFA) or common or external iliac arteries of the target extremity located within the following anatomical parameters:

   Iliac

   • Proximal margin of target lesion is ≥ 2.5 cm distal to the aortic bifurcation in common iliac artery
   • Distal margin of target lesion is ≥ 1.5 cm proximal to the location of inguinal ligament

   SFA

   • Proximal margin of target lesion is ≥ 1 cm distal to the common femoral artery bifurcation
   • Distal margin of target lesion is ≤ 25 cm distal to the common femoral artery bifurcation

2. Vessel diameter from ≥ 5.5 mm to ≤ 6.5 mm evaluated by on-line quantitative vascular angiography (QVA) after pre-dilatation per core laboratory guidelines

3. Target lesion is ≥ 50% DS

4. Target lesion length ≤ 50 mm

5. Patent inflow artery free from significant lesion (≥ 50% DS and < 100% DS) as confirmed by angiography (treatment of the target lesion acceptable after successful treatment of inflow artery lesion)

6. Patent popliteal artery free from significant lesion (≥ 50% DS) with at least one patent distal outflow artery (anterior tibial, posterior tibial, or peroneal) that provides in-line circulation to the lower leg and foot, as confirmed by angiography

Exclusion Criteria

1. A platelet count <100,000 cells/mm3 or >700,000 cells/mm3; a white blood cell count (WBC) <3,000 cells/mm3; or hemoglobin < 10.0 g/dL
2. Acute or chronic renal dysfunction (creatinine > 2.5 mg/dl or >176μmol/L)
3. Severe liver impairment as defined by total bilirubin ≥ 3 mg/dl or two times increase over the normal level of serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT).
4. Known allergies to the following: aspirin, clopidogrel, prasugrel or ticlopidine, heparin, contrast agent (that cannot be adequately premedicated), or drugs similar to everolimus (i.e. tacrolimus, sirolimus, zotarolimus) or other macrolides.
5. Subject requires planned procedure that would necessitate the discontinuation of clopidogrel, prasugrel or ticlopidine.
6. Subject has had or will require treatment with drug eluting stent (DES) or drug coated balloon (DCB) within 6 months pre- or post-index procedure.
7. Subject is unable to walk.
8. Subject has undergone any non-iliac percutaneous intervention, e.g. coronary, carotid, < 30 days prior to the planned index procedure.
9. Subject has received, or is on the waiting list for, a organ transplant.
10. Subject is on chronic hemodialysis.
11. Subject has uncontrolled diabetes mellitus (DM) (HbA1c ≥ 7.0%).
12. Subject has had a myocardial infarction (MI) within the previous 30 days of the planned index procedure.
13. Subject has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limits the subject's ability to walk.
14. Subject has unstable angina defined as rest angina with ECG changes.
15. Subject has a groin infection, or an acute systemic infection that has not been treated successfully or is currently under treatment.
16. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.
17. Subject has other medical illnesses (e.g., cancer or congestive heart failure) that may cause the subject to be non-compliant with protocol requirements, confound the data interpretation or is associated with limited life-expectancy, i.e., less than 12 months.
18. Subject is currently participating in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.)
19. Subject is unable to understand or unwilling to cooperate with study procedures.
20. Subject requires general anesthesia for the procedure.
21. Subject has ischemic or neuropathic ulcers on either foot.
22. Subject has prior minor or major amputation of either lower extremity.
23. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention.

Angiographic Exclusion Criteria

1. Contralateral lesion distal to the location of inguinal ligament that requires treatment within 30 days before or after the procedure. (Contralateral iliac artery lesions may be treated during the procedure if necessary for contralateral approach to the target lesion).

2. Target extremity has an angiographically significant (> 50% DS) lesion located distal to the target lesion.

3. Acute ischemia of the target extremity

4. Target extremity has been previously treated with any of the following: surgical bypass or endarterectomy.

5. Target vessel has been previously treated with any of the following: stent, laser, atherectomy, surgical bypass, or endarterectomy.

6. Total occlusion (100% DS) of the ipsilateral inflow artery.

7. Angiographic evidence of thrombus in target vessel.

8. The target lesion requires treatment with a device other than percutaneous transluminal angioplasty (PTA) (e.g. but not limited to, directional atherectomy, excimer laser, rotational atherectomy, brachytherapy, cryoplasty, etc.)

9. Target lesion is within or adjacent to an aneurysm.

10. Subject has angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion, or from crossing or pre-dilating the target lesion.

11. Target lesion has moderate-to-severe calcification with either of the following characteristics:

    • Circumferential orientation
    • Thickness > 2 mm in either radial or longitudinal direction

12. Subject has an abdominal aortic aneurysm > 3 cm or history of aortic revascularization.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ESPRIT BVS	ESPRIT BVS	Subjects receiving the ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.

Primary Outcome Measures

Name	Time	Method
Device Success	On Day 0 (From start of index procedure to end of index procedure)	Study device success is defined on a per device basis, the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.
Technical Success	On Day 0 (From start of index procedure to end of index procedure)	Technical success is defined on a per lesion basis, the attainment of a final residual stenosis of \< 30% at the intended target lesion(s). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout patients will be included as technical success only if the above criteria are met.
Clinical Success	> or = 2 days after the index procedure	Defined on a per subject basis, as the attainment of a final residual stenosis of \< 30% using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications\* within 2 days after the index procedure or at hospital discharge, whichever is sooner. (Note that in the ESPRIT I study, only a single target lesion per subject is permitted to be treated).; \*Includes the following: Death; Amputation; Scaffold Thrombosis; Target Lesion Revascularization (by any percutaneous or surgical means); Target Vessel Revascularization (by any percutaneous or surgical means).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Ischemia-driven Target Lesion Revascularization (ID-TLR)	3 years	A revascularization of the target lesion is considered ischemia driven if angiography shows a percent diameter stenosis ≥ 50% and there is worsening of the Rutherford Becker Clinical Category that is clearly referable to the target lesion. (worsening is defined as a deterioration (an increase) in the Rutherford Becker Clinical Category by more than 2 categories from the earliest post-procedural measurement or to a category 6.) An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
Number of Participants With Primary Patency	3 years	At the designated follow-up, intervention-free patency (\< 50% diameter stenosis) since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target lesion, or amputation of the extremity due to target lesion restenosis or occlusion.
In-Scaffold Peak Systolic Velocity Ratio (PSVR)	2 years	Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound
Treated Site Late Loss	12 months	Mean in-lesion Late Loss is calculated as: (MLD post-procedure - MLD follow-up).; The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, treated site or treated segment. Minimum Lumen Vessel Diameter (MLD) is visually estimated during angiography by the Investigator; it is measured during qualitative comparative analysis (QCA) by the Angiographic Core Lab.
Number of Participants With Any Amputation of Treated Limb (Minor and Major)	3 years	The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.; A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
In-scaffold Peak Systolic Velocity (PSV)	3 years	In-scaffold Peak Systolic Velocity (PSV) as Measured by Duplex Ultrasound
Treated Site Percent Diameter Stenosis (%DS)	12 months	Percent diameter stenosis (%DS) value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QA.; * Reference Vessel Diameter (RVD); * Minimum Luminal Diameter(MLD)
Quality of Life Measures: Physical Functioning (PF) Summary	At 3 years	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Number of Participants With Limb Salvage (Freedom From Ipsilateral Major Amputations) of the Target Extremity	0 to 1095 days	Amputation: The removal of a body extremity by surgery. For this study, the definition of amputation will only apply to amputations of the limb that was treated.; A minor amputation will be defined as below-the-ankle; and a major amputation will be defined as limb loss at or proximal to the transtibial level. Major amputations will be specified as below-the-knee and above-the-knee amputations.
Scaffold Occlusion	1 month	Number of participants with Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs \> 30 days post-index procedure.
Number of Participants With Scaffold Occlusion	0 to 3 years	Scaffold Occlusion is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs \> 30 days post-index procedure.
Number of Participants With Target Lesion Revascularization (TLR)	3 years	Target lesion revascularization (TLR) is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Number of Participants With Ipsilateral Extremity Revascularization (IER)	3 years	Ipsilateral extremity revascularization (IER) also called as Target extremity revascularization (TER). References to "target" lesion or extremity revised to "ipsilateral" lesion or extremity.; Ipsilateral extremity revascularization (IER) is defined as any percutaneous intervention or surgical bypass of any segment of the ipsilateral extremity. The ipsilateral extremity is defined as the ipsilateral limb arteries proximal and distal to the target lesion, which includes upstream and downstream branches and excludes the target lesion itself.
Number of Participants With Rutherford Becker Clinical Category Summary for the Treated Limb	3 years	The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.; Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Walking Impairment Questionnaire (WIQ) Scores	At 1 month	Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication.; The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
Walking Impairment Questionaire Scores	At 3 years	Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).
In-scaffold Peak Systolic Velocity Ratio (PSVR)	3 years	Peak Systolic Velocity Ratio (PSVR) as measured by duplex ultrasound
Number of Participants With Death	3 years	Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.); -Non-cardiac death is defined as a death not due to cardiac causes (as defined above).
Number of Participants With Scaffold Thrombosis	0 to 1 month	Scaffold Thrombosis is defined as total occlusion identified within the scaffold by arteriography and/or ultrasound that occurs within 30 days post- index procedure.
Ankle Brachial Index (ABI) for the Treated Limb	At 3 years	The ABI is the ratio of the ankle to arm pressure, and it is calculated by dividing the systolic blood pressure in the ankle of the one leg by the higher of the two systolic blood pressures in the arms.; An ABI of 0.9 - 1.3 is a normal range. A reduced ABI (less than 0.9) is consistent with peripheral artery occlusive disease, with values below 0.8 indicating moderate disease and below 0.5 indicates severe disease. A value greater than 1.3 is considered abnormal suggesting calcification of the walls of the arteries and noncompressible vessels, reflecting severe peripheral vascular disease. Subjects with ABI values greater than 1.3 will be excluded from the analysis.; Calculation of the Ankle Brachial Index: (Highest Ankle Systolic Pressure/Highest Brachial Systolic Pressure = ABI)
Binary Restenosis (≥50% DS)	1 year	Binary restenosis is defined as the presence of a hemodynamically significant stenosis ≥ 50% as determined by duplex ultrasound or quantitative angiography (QA).; Scaffold Stenosis ≥ 50% by Duplex Ultrasound Only; In-scaffold %DS ≥ 50% by Arteriogram Only
Quality of Life Measures: Role Physical (RP) Summary	At 3 years	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Quality of Life Measures: Bodily Pain (BP) Summary	At 3 years	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Quality of Life Measures: General Health (GH) Summary	At 3 years	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Quality of Life Measures: Role Emotional (RE) Summary	At 3 years	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Quality of Life Measures: Physical Component Summary (PCS)	At 3 years	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Quality of Life Measures: Mental Component Summary (MCS)	At 3 years	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Vascular Quality of Life (VascuQol) Scores Summary	At 3 years	Vascular Quality of Life Questionnaire is defined as a disease specific quality of life (QOL) measure for subjects with chronic lower limb ischemia. Each item is rated as a seven point response scale, with a score of one being the worst and a score of seven the best possible. The total average score is the sum of all 25 items scores divided by 25. For each separate domain an average score can be calculated (sum of all items of one domain divided by the number of items of that domain). The highest score for each domain is 7, which indicates best health outcome.; The domains include Activity Domain, Symptom Domain, Pain Domain, Emotional Domain, Social Domain.
Quality of Life Measures: Vitality (VT) Summary	At 3 years	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Quality of Life Measures: Social Functioning (SF) Summary	At 3 years	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Quality of Life Measures: Mental Health (MH) Summary	At 3 years	The 12-Item Short Form Health Survey (SF-12) questionnaire was used to determine general Quality of Life (QOL) measurements.; SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

Trial Locations

Locations (8)

Abbott Vascular International BVBA; 🇧🇪 Brussels, Belgium

Sint-Blasius Hospital; 🇧🇪 Dendermonde, Belgium

Medical University of Vienna; 🇦🇹 Vienna, Austria

Oost Limburg Ziekenhuis; 🇧🇪 Genk, Belgium

Gent University Hospital; 🇧🇪 Gent, Belgium

Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Clinique Pasteur; 🇫🇷 Toulouse, France

Park-Krankenhaus Leipzig; 🇩🇪 Leipzig, Germany