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Clinical Trials/NCT01575808
NCT01575808CompletedNot Applicable

The Utility of GP1101 Relative to Surgical Bypass in the Treatment of Femoral / Popliteal Arterial Symptomatic Peripheral Arterial Disease

W.L.Gore & Associates15 sites in 1 country133 target enrollmentStarted: April 1, 2012Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
133
Locations
15
Primary Endpoint
Primary Assisted Patency
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease. Efficacy will be measured by comparison to a Surgical Bypass Efficacy Goal, and Invasiveness will be measured by comparison to Surgical Bypass data derived from a retrospective study.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Rutherford 2-5 category
  • •Subject has read, understood and signed written informed consent which has been reviewed and approved by the Institutional Review Board (IRB).
  • •At least 20 years of age.
  • •Ankle-brachial index (ABI) in the study limb in the non-invasive lower extremity arterial studies within 30 days prior to study procedure or at the time of study procedure is less than or equal to 0.9, or toe-brachial index (TBI) is less than or equal to 0.
  • •Male, infertile female, or female of child-bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure.
  • •Projected life expectancy of greater than 2 years.
  • •The ability to comply with the study protocol, follow-up requirements and required testing.
  • •Surgical bypass candidate
  • •Qualifying lesions by angiography

Exclusion Criteria

  • •Untreated flow-limiting aortoiliac disease.
  • •Any previous stenting or surgery in the target vessel(i.e. femoro-popliteal artery).
  • •Vascular access/catheterization in the target or contralateral limb within 30 days of study enrollment.
  • •Planned surgery or intervention within 30 days after study procedure.
  • •Femoral artery or popliteal artery aneurysm > 1.5 X healthy adjacent vessel diameter.
  • •Non-atherosclerotic disease resulting in stenosis and/or occlusion (e.g., embolism, Buerger's disease, vasculitis).
  • •Severe medical comorbidities (untreated CAD/CHF (Congestive Heart Failure), severe COPD (Chronic Obstructive Pulmonary Disease), severe dementia, NYHA (New York Heart Association) 3/4, severe hypertension, etc.)
  • •Any medical condition that would preclude post-procedural ambulation or completion of study follow-up.
  • •Rutherford 5 patients with active infection.
  • •Serum creatinine >2.5 mg/dL within 30 days prior to study procedure.
  • •Rutherford 6 category in the study or non-study limb or major tissue loss extending above the proximal phalanx level.
  • •Rutherford 5 characteristics in non-study limb.
  • •Major distal amputation (above the transmetatarsal) in the study or non-study limb.
  • •Active infection that could adversely impact patient outcomes in the study, or any patient with septicemia or bacteremia.
  • •Any previously known coagulation disorder, including hypercoagulability.
  • •Morbid obesity or operative scarring that precludes percutaneous approach
  • •Contraindication to anticoagulation or antiplatelet
  • •Known allergies to stent/stent-graft components, including heparin sensitivity, allergy, or previous incidence of heparin-induced thrombocytopenia (HIT) type II.
  • •Current peritoneal or hemodialysis
  • •Participation in another clinical trial (except F/P device clinical trial) up to 3 months prior to study enrollment.
  • •Enrollment in a F/P device clinical trial within the last 12 months.
  • •Interventional or surgical treatment on arteries distal to the target vessel for this study within the past 12 months.
  • •Any other factor identified by the Principal Investigator

Arms & Interventions

GP1101

Experimental

Prospective data collection: Subjects with occlusive disease of the SFA (Superficial Femoral Artery) implanted with GP1101 covered stent graft

Intervention: GP1101 (Device)

Retrospective Surgical Bypass Outcomes

No Intervention

Retrospective data collection (Apr 2012 - Apr 2014) of 68 surgical procedures (performed after Jan 2002) at six Japanese centers used to treat femoral-popliteal artery symptomatic PAD for purposes of establishing the invasiveness control data for hospital stay duration, avoidance of general anesthesia and avoidance of intra-operative transfusion. Eligibility criteria for inclusion werer established to be consistent with the experimental arm.

Outcomes

Primary Outcomes

Primary Assisted Patency

Time Frame: 12 months

Primary Efficacy Endpoint \> \> Primary assisted patency at 12 months, defined as hemodynamic evidence by Angiography or ultrasound of flow through a device that had not required a Target Lesion Revascularization (TLR) to restore blood flow after total occlusion

Rate of Avoidance of General Anesthesia

Time Frame: Day 0

Percentage of study subjects avoiding general anesthesia

Duration of Stay

Time Frame: Up to discharge

Duration (in days) of post-procedure hospital stay

Secondary Outcomes

  • Walking Impairment Questionnaire-WIQ(24 months)
  • Percent of Participants Not Experiencing an Adverse Event(48 months)
  • Primary Patency(24 months)
  • Rate of Avoidance of Stent Fracture(24 months)
  • Avoidance of Target Lesion Revascularization(24 months)
  • Technical Success(Post-procedure)
  • Clinical Success(24 months)
  • Vascular Quality of Life Questionnaire - VascuQOL(24 months)
  • Rate of Avoidance of Blood Transfusion(Post-Procedure)
  • Secondary Patency(24 months)
  • Number of Participants Who Did Not Experience Any Critical Events(Death, Target Vessel Revascularization, Major Amputation of the Target Limb)(1 month)
  • Rate of Avoidance of Adverse Events(60 months)
  • Change in Ankle-Brachial Index From Baseline(Baseline and 1, 3, 6, 12, 24 months, change from baseline at 24 months presented)
  • Avoidance of Target Lesion Revascularization(12 months)
  • Percent of Participants Not Experiencing an Adverse Event(1 month)
  • Avoidance of Target Lesion Revascularization(1 month)
  • Avoidance of Target Lesion Revascularization(3 months)
  • Percent of Participants Not Experiencing an Adverse Event(3 months)
  • Percent of Participants Not Experiencing an Adverse Event(6 months)
  • Percent of Participants Not Experiencing an Adverse Event(12 months)
  • Percent of Participants Not Experiencing an Adverse Event(24 months)
  • Percent of Participants Not Experiencing an Adverse Event(36 months)
  • Avoidance of Target Lesion Revascularization(6 months)
  • Primary Patency(1 month)
  • Primary Patency(3 months)
  • Primary Patency(6 months)
  • Primary Patency(12 months)
  • Secondary Patency(1 month)
  • Secondary Patency(3 months)
  • Secondary Patency(6 months)
  • Secondary Patency(12 months)
  • Rate of Avoidance of Stent Fracture(1 month)
  • Rate of Avoidance of Stent Fracture(3 months)
  • Rate of Avoidance of Stent Fracture(6 months)
  • Rate of Avoidance of Stent Fracture(12 months)
  • Clinical Success(1 month)
  • Clinical Success(3 months)
  • Clinical Success(6 months)
  • Clinical Success(12 months)
  • Change in Ankle-Brachial Index From Baseline(Baseline and 1, 3, 6, 12, 24 months, change from baseline at 1 month presented)
  • Change in Ankle-Brachial Index From Baseline(Baseline and 1, 3, 6, 12, 24 months, change from baseline at 3 months presented)
  • Change in Ankle-Brachial Index From Baseline(Baseline and 1, 3, 6, 12, 24 months, change from baseline at 6 months presented)
  • Change in Ankle-Brachial Index From Baseline(Baseline and 1, 3, 6, 12, 24 months, change from baseline at 12 months presented)
  • Vascular Quality of Life Questionnaire - VascuQOL(1 month)
  • Vascular Quality of Life Questionnaire - VascuQOL(3 months)
  • Vascular Quality of Life Questionnaire - VascuQOL(6 months)
  • Vascular Quality of Life Questionnaire - VascuQOL(12 months)
  • Walking Impairment Questionnaire-WIQ(1 month)
  • Walking Impairment Questionnaire-WIQ(3 months)
  • Walking Impairment Questionnaire-WIQ(6 months)
  • Walking Impairment Questionnaire-WIQ(12 months)

Investigators

Sponsor
W.L.Gore & Associates
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (15)

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