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.

Abbott Medical Devices1 site in 1 country141 target enrollmentOctober 2011

ConditionsPeripheral Artery Disease Peripheral Vascular Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Artery Disease
Sponsor: Abbott Medical Devices
Enrollment: 141
Locations: 1
Primary Endpoint: Freedom From Vessel Patency
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

May 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

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:

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.

Outcomes

Primary Outcomes

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.

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)

Secondary Outcomes

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)
Any Target Lesion Revascularization (TLR)(At 1 year)
Death(At 1 year)
Freedom From Stent Patency(0 to 379 days)
Stent Integrity by X-ray(12 months)
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)
Freedom From Ipsilateral Major Amputation(0 to 379 days)
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))
Quality of Life Measures : Physical Functioning (PF)(1 year)
Quality of Life Measures : Role Physical (RP)(1 year)
Quality of Life Measures : General Health (GH)(1 year)
Quality of Life Measures : Bodily Pain (BP)(1 year)
Quality of Life Measures : Vitality (VT)(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 : Mental Component Summary (MCS)(1 year)
Vascular Quality of Life (VascuQol) Total Scores(1 year)
Acute Success : Technical Success(With in 2 days of index post procedure)