NCT01444378CompletedNot Applicable
Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent Systems in the Treatment of Subjects With Atherosclerotic De Novo or Restenotic Lesions in the Native Superficial Femoral Artery and/or Native Proximal Popliteal Artery.
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 141
- Locations
- 1
- Primary Endpoint
- Major Adverse Event (MAE)
Study Overview
Brief Summary
To evaluate the safety and effectiveness of the Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent System for the treatment of subjects with atherosclerotic de novo or restenotic lesions in the native superficial femoral artery (SFA) and/or the native proximal popliteal artery (PPA).
CAUTION: Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent Systems are investigational devices. Limited by Federal (U.S.) law to investigational use only.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •General Clinical Inclusion Criteria:
- •Subject is ≥ 18 years of age.
- •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.
- •Subject agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.
- •Subject is diagnosed as having moderate to severe claudication (Rutherford-Becker Clinical Category 2-3) or ischemic rest pain (Rutherford-Becker Clinical Category 4).
- •Female subject of childbearing potential must:
- •have had a negative pregnancy test (serum HCG) within 14 days before treatment;
- •not be nursing at the time of treatment; and
- •agree at time of consent to use birth control during participation in this trial.
- •Subject has life expectancy > 12 months.
- •Angiographic Inclusion Criteria:
- •A single de novo or restenotic [not previously treated with stent, brachytherapy, laser, surgical bypass, or endarterectomy] native disease segment of the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) located within the following parameters: ≥1 cm below the femoral bifurcation in the SFA. ≥3 cm above the proximal margin of the intercondylar fossa.
- •Disease segment length visually estimated to be ≤ 14 cm (140 mm) and can be treated with one stent.
- •Disease segment visually estimated to be ≥ 50% stenosis or a total occlusion.
- •Target vessel reference diameter visually estimated to be ≥ 4.0 mm and ≤ 7.0 mm.
- •A patent ipsilateral iliac artery, defined as < 50% stenosis, as confirmed by arteriography.
- •At least one patent distal outflow artery (anterior tibial, posterior tibial, peroneal) defined as < 50% stenosis, that provides in-line circulation to the lower leg and foot.
- •Total occlusion length ≤ 8 cm.
- •General Clinical
Exclusion Criteria
- •Subject is unable to walk.
- •Subject has undergone any non-iliac percutaneous intervention, e.g. coronary, carotid, < 30 days prior to the planned index procedure.
- •Subject has received, or is on the waiting list for, a major organ transplant.
- •Subject is diagnosed as Rutherford-Becker Clinical Category 5 or 6 in either extremity.
- •Subject is diagnosed as Rutherford-Becker Clinical Category 0 or 1 in the target extremity (i.e., where the investigational stent will be placed).
- •Subject has elevated serum creatinine > 2.5 mg/dl.
- •Subject is on chronic hemodialysis.
- •Subject has documented or suspected uncontrolled diabetes mellitus (DM), unless HbA1c has been assessed as < 7.0% within 3 months prior to index procedure.
- •Subject has had a myocardial infarction (MI) within the previous 30 days of the planned index procedure.
- •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.
- •Subject has unstable angina defined as rest angina with ECG changes.
- •Subject has a groin infection, or an acute systemic infection that has not been treated successfully or is currently under treatment.
- •Subject has acute thrombophlebitis or deep vein thrombosis in either extremity.
- •Subject is unable to take required antiplatelet therapy or requires any planned procedure that would necessitate the discontinuation of clopidogrel, prasugrel, ticagrelor or ticlopidine within 30 days following the procedure.
- •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 1 year.
- •Subject is currently participating in an investigational drug, biologic, or device study.
- •Subject is unable to understand or unwilling to cooperate with study procedures.
- •Subject is allergic to nickel, titanium, platinum, contrast media, or any study-required medication that is not amenable to pre-treatment.
- •Subject has a known bleeding or hypercoagulability disorder or significant anemia (Hgb < 8.0) that cannot be corrected.
- •Subject requires general anesthesia for the procedure.
- •Subject has ischemic or neuropathic ulcers on either foot.
- •Subject has had any type of amputation to the ipsilateral extremity, or a contralateral extremity amputation other than of the toe or forefoot.
- •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:
- •Total occlusion of the ipsilateral iliac artery.
- •Target extremity has multilevel disease that requires other staged procedures within 30 days before or after the procedure.
- •Target extremity has been previously treated with any of the following: surgical bypass or endarterectomy.
- •Target vessel has an angiographically significant (> 50% DS) lesion located distal to the target lesion that requires treatment at the time of the index procedure or by a staged procedure within 30 days before or after the procedure.
- •Target vessel has been previously treated at any location with a stent, or has been previously treated ≤ 5 cm from the proximal or distal margin of the target lesion with brachytherapy or laser.
- •Target lesion is within or adjacent to an aneurysm.
- •Target lesion or vessel has angiographic evidence of thrombus that is unresponsive to anti-thrombotic therapies.
- •Subject has a contralateral superficial femoral or proximal popliteal artery lesion that requires treatment within 30 days before or after the procedure.
- •Subject has a history of aortic revascularization or has an abdominal aortic aneurysm > 3 cm.
- •Subject has evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion.
- •.Subject has any condition that precludes safe access to the target lesion or target vessel, e.g. severe calcification, excessive tortuosity.
- •Target lesion requires use of re-entry, ablative, cutting balloon, atherectomy, or similar devices to cross or treat the lesion.
Arms & Interventions
Absolute Pro® and Pro LL® Peripheral Stent Systems
Experimental
Intervention: Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems (Device)
Outcomes
Primary Outcomes
Major Adverse Event (MAE)
Time Frame: 30 days
Primary safety endpoint is freedom from MAE which is defined as a composite of: * Death due to all causes * Index limb major amputation (at or above the ankle) * Clinically-driven target lesion revascularization (TLR)
Freedom From Vessel Patency
Time Frame: 0 to 365 days
This is the primary effectiveness endpoint which is defined as the absence of in-stent restenosis (≥ 50%) as determined by duplex ultrasonography or arteriography and without clinically driven TLR. The vessel patency rate was estimated by the Kaplan-Meier method with the standard error estimated using the Greenwood formula.
Secondary Outcomes
- Death(At 1 year)
- Freedom From Ipsilateral Major Amputation(0 to 379 days)
- Any Target Lesion Revascularization (TLR)(At 1 year)
- Freedom From Stent Patency(0 to 379 days)
- Freedom From Any Ipsilateral Amputation(0 to 379 days)
- Embolic Events in the Treated Limb (as Reported by Site)(At 1 year)
- Rutherford-Becker Clinical Category for the Treated Limb(12 months)
- Toe Brachial Index (TBI)(At 1 year)
- Stent Occlusion(> 30 Days Post Study Procedure)
- In-Stent Percent Diameter Stenosis (%DS)(Post-Procedure (≥ 1 day))
- Acute Stent Thrombosis(0 - 24 Hours Post Study Procedure)
- Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV)(12 months)
- Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR)(12 months)
- Sub-Acute Stent Thrombosis(> 24 Hours - 30 Days Post Study Procedure)
- In-Segment Percent Diameter Stenosis (%DS)(Post-Procedure (≥ 1 day))
- Acute Success : Technical Success(With in 2 days of index post procedure)
- Quality of Life Measures : Role Physical (RP)(1 year)
- Quality of Life Measures : General Health (GH)(1 year)
- Quality of Life Measures : Social Functioning (SF)(1 year)
- Quality of Life Measures : Role Emotional (RE)(1 year)
- Quality of Life Measures : Mental Health (MH)(1 year)
- Quality of Life Measures : Bodily Pain (BP)(1 year)
- Quality of Life Measures : Vitality (VT)(1 year)
- Quality of Life Measures : Mental Component Summary (MCS)(1 year)
- Vascular Quality of Life (VascuQol) Total Scores(1 year)
- Quality of Life Measures : Physical Functioning (PF)(1 year)
- Stent Integrity by X-ray(12 months)
- Acute Success : Device Success(With in 2 days of index post procedure)
- Freedom From Vessel Patency(0 to 180 days)
- Acute Success : Clinical Success(With in 2 days after index post procedure or at hospital discharge (before 1 month))
- Clinically-driven Target Lesion Revascularization (CD-TLR)(At 1 year)
- Target Vessel Revascularization (TVR)(At 1 year)
- Walking Impairment Questionnaire Scores(12 months)
- Maximum Walking Distance(12 months)
- Quality of Life Measures : Physical Component Summary (PCS)(1 year)
- Ankle Brachial Index (ABI) for the Treated Limb(12 months)
- Maximum Walking Distance(Pre-procedure)
- Maximum Walking Distance(1 month)
- Maximum Walking Distance(6 months)
- Freedom From Vessel Patency(0 to 30 days)
- Ankle Brachial Index (ABI) for the Treated Limb(Pre-Procedure)
- Ankle Brachial Index (ABI) for the Treated Limb(1 month)
- Ankle Brachial Index (ABI) for the Treated Limb(6 months)
- Clinically-driven Target Lesion Revascularization (CD-TLR)(At 1 month)
- Clinically-driven Target Lesion Revascularization (CD-TLR)(At 6 months)
- Any Target Lesion Revascularization (TLR)(At 1 month)
- Any Target Lesion Revascularization (TLR)(At 6 months)
- Target Vessel Revascularization (TVR)(At 1 month)
- Target Vessel Revascularization (TVR)(At 6 months)
- Death(At 1 month)
- Death(At 6 months)
- Freedom From Stent Patency(0 to 30 days)
- Freedom From Stent Patency(0 to 180 days)
- Freedom From Stent Patency(0 to 365 days)
- Freedom From Any Ipsilateral Amputation(At day 0 (on the day of index procedure))
- Freedom From Any Ipsilateral Amputation(0 to 30 days)
- Freedom From Any Ipsilateral Amputation(0 to 180 days)
- Freedom From Any Ipsilateral Amputation(0 to 365 days)
- Embolic Events in the Treated Limb (as Reported by Site)(At 1 month)
- Embolic Events in the Treated Limb (as Reported by Site)(At 6 months)
- Rutherford-Becker Clinical Category for the Treated Limb(Pre-procedure)
- Rutherford-Becker Clinical Category for the Treated Limb(1 month)
- Toe Brachial Index (TBI)(At 1 month)
- Rutherford-Becker Clinical Category for the Treated Limb(6 months)
- Walking Impairment Questionnaire Scores(Pre-procedure)
- Walking Impairment Questionnaire Scores(1 month)
- Walking Impairment Questionnaire Scores(6 months)
- Toe Brachial Index (TBI)(At 6 months)
- Duplex Ultrasound: Maximum In-Stent Peak Systolic Velocity (PSV)(1 month)
- Duplex Ultrasound: In-Stent Peak Systolic Velocity Ratio (PSVR)(1 month)
- In-Segment Percent Diameter Stenosis (%DS)(Pre-Procedure)
- Freedom From Ipsilateral Major Amputation(At day 0 (on the day of index procedure))
- Freedom From Ipsilateral Major Amputation(0 to 30 days)
- Freedom From Ipsilateral Major Amputation(0 to 180 days)
- Freedom From Ipsilateral Major Amputation(0 to 365 days)
- Quality of Life Measures : Physical Functioning (PF)(1 month)
- Quality of Life Measures : Physical Functioning (PF)(6 months)
- Quality of Life Measures : Role Physical (RP)(1 month)
- Quality of Life Measures : Role Physical (RP)(6 months)
- Quality of Life Measures : Bodily Pain (BP)(1 month)
- Quality of Life Measures : Bodily Pain (BP)(6 months)
- Quality of Life Measures : General Health (GH)(1 month)
- Quality of Life Measures : General Health (GH)(6 months)
- Quality of Life Measures : Vitality (VT)(1 month)
- Quality of Life Measures : Vitality (VT)(6 months)
- Quality of Life Measures : Social Functioning (SF)(1 month)
- Quality of Life Measures : Social Functioning (SF)(6 months)
- Quality of Life Measures : Role Emotional (RE)(1 month)
- Quality of Life Measures : Role Emotional (RE)(6 months)
- Quality of Life Measures : Mental Health (MH)(1 month)
- Quality of Life Measures : Mental Health (MH)(6 months)
- Quality of Life Measures : Physical Component Summary (PCS)(1 month)
- Quality of Life Measures : Physical Component Summary (PCS)(6 months)
- Quality of Life Measures : Mental Component Summary (MCS)(1 month)
- Quality of Life Measures : Mental Component Summary (MCS)(6 months)
- Vascular Quality of Life (VascuQol) Total Scores(1 month)
- Vascular Quality of Life (VascuQol) Total Scores(6 months)
Investigators
Study Sites (1)
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