N/A
Completed N=171
Multi-center Study for Stent Graft System for Peripheral Artery
Source: ClinicalTrials.gov NCT01575808 ↗Enrolled (actual)
171
Serious AEs
45.6%
Results posted
Feb 2018
Primary outcomePrimary: Primary Assisted Patency — 91 Participants — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Assisted Patency |
91 | <0.0001 sig |
| PRIMARY Duration of Stay |
2.0; 12.5 | <0.0001 sig |
| PRIMARY Rate of Avoidance of General Anesthesia |
103; 17 | <0.0001 sig |
| SECONDARY Number of Participants Who Did Not Experience Any Critical Events(Death, Target Vessel Revascularization, Major Amputation of the Target Limb) |
103 | — |
| SECONDARY Percent of Participants Not Experiencing an Adverse Event |
— | — |
| SECONDARY Rate of Avoidance of Adverse Events |
— | — |
| SECONDARY Technical Success |
102 | — |
| SECONDARY Primary Patency |
— | — |
| SECONDARY Secondary Patency |
— | — |
| SECONDARY Rate of Avoidance of Stent Fracture |
— | — |
| SECONDARY Avoidance of Target Lesion Revascularization |
— | — |
| SECONDARY Clinical Success |
— | — |
| SECONDARY Change in Ankle-Brachial Index From Baseline |
— | — |
| SECONDARY Vascular Quality of Life Questionnaire - VascuQOL |
— | — |
| SECONDARY Walking Impairment Questionnaire-WIQ |
— | — |
| SECONDARY Rate of Avoidance of Blood Transfusion |
103 | — |
Eligibility Criteria
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 0.5.
- 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
Data sourced from ClinicalTrials.gov (NCT01575808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.