Trial to Evaluate the Safety & Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery.

Phase 3

Completed

• Conditions: Peripheral Vascular Disease
• Interventions: Device: Absolute Pro™ Peripheral Self-Expanding Stent System

• Registration Number: NCT00844532
• Lead Sponsor: Abbott Medical Devices

Brief Summary

To determine the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-13
• Study First Posted: 2009-02-16
• Study Start: 2009-03
• Primary Completion: 2011-03
• Disposition First Submitted: 2011-12-07
• Disposition First Submitted QC: 2012-02-28
• Disposition First Posted: 2012-03-01
• Results First Submitted: 2012-03-30
• Results First Submitted QC: 2012-08-07
• Results First Posted: 2012-09-07
• Study Completion: 2014-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-14
• Last Update Posted: 2015-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

1. Subject must be at least 18 and < 90 years of age.
2. Subject has been informed of the nature of the trial, agrees to its provisions, and has signed the informed consent form.
3. Subject must agree to undergo all protocol-required follow-up examinations and requirements at the investigational site.
4. History of symptomatic claudication (Rutherford Becker Clinical Category 2-3) or ischemic rest pain (Rutherford Becker Clinical Category 4).
5. Female subjects of childbearing potential must have had a negative pregnancy test before treatment, and must not be nursing at the time of treatment, and agree at time of consent to use birth control during participation in this trial up to and including the follow-up at 9 months.

Angiographic Inclusion Criteria

1. Up to two bilateral de novo or restenotic lesions of the native common iliac artery and/or native external iliac artery may be treated(one per side).
2. Common iliac artery lesion visually estimated to be ≥50% stenosis and ≤100% stenosis (total occlusion)
3. External iliac artery lesion visually estimated to be ≥50% stenosis and ≤99% stenosis
4. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 110 mm (Absolute Pro)
5. Lesion length for total occlusion of the common iliac artery visually estimated to be ≤40 mm
6. Target vessel reference diameter visually estimated to be ≥3.6 mm and ≤9.1 mm (Absolute Pro)
7. On the treatment side(s), patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as < 50% stenosis.
8. Lesion length for stenosis of the common or external iliac artery visually estimated to be ≥ 10 mm and ≤ 50 mm (Omnilink Elite).
9. Target vessel reference diameter visually estimated to be ≥ 5.0 mm and ≤ 11.0 mm (Omnilink Elite).

Clinical Exclusion Criteria

1. Subject is unable to walk.
2. Subject has had recent major surgery (last 3 months) e.g., abdominal surgery, coronary artery bypass graft surgery, thoracic surgery.
3. Subject has received, or is on the waiting list for a major organ transplant (heart, lung, kidney, liver).
4. Subject is diagnosed as Rutherford Becker Clinical Category 0, 1, 5, or 6.
5. Subject has ulcers or lesions on the lower extremity(ies) of the target lesion side(s).
6. Subject has elevated serum creatinine > 2.0 mg/dl.
7. Subject has uncontrolled diabetes mellitus (DM) (serum glucose > 400 mg/dl).
8. Subject has had a myocardial infarction(MI)(Q-wave or NQWMI) within the previous 30 days.
9. Subject has had a stroke within the previous 30 days and/or has deficits from a prior stroke that limits the subjects ability to walk.
10. Subject has unstable angina defined as rest angina with ECG changes.
11. Subject has a groin infection, or an acute systemic infection that is currently under treatment.
12. Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.
13. Subject requires any planned procedure within 30 days after the index procedure that would necessitate the discontinuation of aspirin, clopidogrel or ticlopidine following the procedure.
14. 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 2 years).
15. Subject is currently participating in an investigational drug or device trial that has not completed the primary endpoint follow-up or that clinically interferes with the current trial endpoints.
16. Subject is unable to understand or unwilling to cooperate with trial procedures or is unwilling or unable to return to the treatment center for follow-up visits.
17. If intended stent is Absolute Pro, subject has known hypersensitivity or contraindication to nickel, titanium or platinum; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication.
18. Subject has known allergy or contraindication to aspirin or clopidogrel (Plavix®); if allergy or contraindication is to clopidogrel, subject is unable to tolerate ticlopidine (Ticlid®).
19. Subject has known bleeding disorder or hypercoagulable disorder, or will refuse blood transfusions.
20. Subject has suffered a gastrointestinal (GI) bleed within 30 days before the index procedure that would interfere with antiplatelet therapy.
21. If intended stent is Omnilink Elite, subject has known hypersensitivity or contraindication to cobalt chromium; subject has known hypersensitivity or contraindication to standard intraprocedure anticoagulant(s); subject has sensitivity to contrast which cannot be adequately pre-treated with medication.
22. Requirement of general anesthesia or spinal block for the procedure.
23. Presence of contralateral limb amputation that was performed to treat any non-traumatic disease in that limb, e.g. atherosclerotic, vascular, neuropathic.
24. Presence of bypass conduit in any outflow vessel, i.e. SFA, popliteal, anterior tibial, posterior tibial, peroneal, ipsilateral to the target lesion.
25. Subject requires a concomitant percutaneous endovascular procedure in another vessel, e.g. coronary.
26. Target lesion is in an iliac artery that has been previously stented.

Angiographic Exclusion Criteria

1. Subject has a totally occluded (100% stenosis) external iliac artery ipsilateral to the target lesion.
2. Subject has a totally occluded (100% stenosis) outflow artery (SFA) ipsilateral to the target lesion
3. Target lesion is within or adjacent to an aneurysm.
4. Lesion is located within or beyond a vessel that contains a bypass graft.
5. Lesion(s) requires atherectomy (or ablative devices) to facilitate stent delivery.
6. Subject has a history of aortic revascularization or has an abdominal aortic aneurysm > 3cm.
7. Lesion extends beyond the inguinal ligament.
8. Subject has angiographic evidence of thrombus in the target disease segment or vessel that is unresponsive to anti-thrombotic therapies.
9. Subject has multilevel disease in the target extremity that requires other staged procedures within 30 days before or after the procedure.
10. On the treatment side(s), subject is without patent superficial femoral and popliteal arteries and at least one patent distal outflow artery with in-line distal vessel flow to the foot as confirmed by arteriography. Patent is defined as < 50% stenosis.
11. Requirement for > 1 stent to treat full length of lesion.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Absolute Pro™ Peripheral Self-Expanding Stent System	Absolute Pro™ Peripheral Self-Expanding Stent System	Arm includes both Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems

Primary Outcome Measures

Name	Time	Method
Major Adverse Event (MAE) Rate	9 months	Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).

Secondary Outcome Measures

Name	Time	Method
Restenosis	3 years	Defined as ≥ 50% stenosis at follow-up.
Device Success	acute: from beginning of index procedure to end of index procedure.	On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).
Technical Success	acute: from beginning of index procedure to end of index procedure.	Technical success is defined, on per target lesion basis, device success and attainment of a final in-stent residual stenosis of \< 30% by QA or as reported by the investigator, if QA is not available.
Procedure Success	Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner	Procedure success is defined, per patient basis, as technical success without any of the following complications; death due to all causes, myocardial infarction (MI), major amputation of the treated limb(s), stent thrombosis and target lesion revascularization (TLR) within two (2) days after the index procedure or at hospital discharge, whichever is sooner.
Thigh Brachial Index (TBI) for the Treated Limb(s)	3 years	The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)	3 years	The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Walking Impairment Questionaire Scores	3 years	Measured by the Walking Impairment Questionnaire (WIQ)
Rutherford Becker Clinical Category for the Treated Limb(s)	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 = 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
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)	Between baseline and 3 years	Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.; Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)	3 years	Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)	3 years	Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has \<50% stenosis, while treating a non-target lesion in the target vessel).
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)	3 years	Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)	3 years	Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)	3 years	Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Primary Stent Patency	3 years	Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.
Kaplan-Meier Estimate of Freedom From Death (All Cause)	3 years	Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)	3 years	The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)	3 years	Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.
Kaplan-Meier Estimate of Freedom From Embolic Events	3 years	Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery
Stent Thrombosis	1 month	Stent thrombosis is defined as a total occlusion documented by DUS and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.
Changes in Quality of Life Measures: Physical Component Summary	Baseline and 3 years	This measure indicates the absolute change between two timepoints represented by the mean.; 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.
Changes in Quality of Life Measures: Mental Component Summary	Baseline and 3 years	This measure indicates the absolute change between two timepoints represented by the mean.; 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 (1)

Abbott Vascular; 🇺🇸 Santa Clara, California, United States