Claudication, Rest Pain, Superficial Femoral Artery Occlusion, Superficial Femoral Artery Stenosis
Conditions
Keywords
Claudication, SFA, Open Bypass, Angioplasty, Stenting
Brief summary
This is a prospective randomized controlled trial to compare clinical improvement, cost effectiveness and patency rates between new and improved Nitinol stents and open bypass surgery in the superficial femoral artery disease. Secondary outcomes also include comparing quality of life, re-intervention rate, mortality, morbidity and time to return to work or regular activities. Patients with superficial femoral artery lesions will be considered. Patients with TASC II A lesions will not be randomized but treated with PTA/stenting as standard of care. Patients with TASC II B and C lesions will be prospectively randomized into either receiving open bypass or stenting. Patients with TASC D lesions will be treated with open bypass surgery after angiography. The investigators will collect pre-procedure, peri-procedural and clinical follow-up data on all enrolled the patients.
Interventions
PROCEDUREOpen Bypass Surgery
Open Bypass Surgery with Autogenous vein or PTFE Graft
PROCEDUREAngioplasty and Stenting
Angioplasty and Stenting of the superficial Femoral artery with Nitinol stent (Life Stent flexStar Stent System by Bard Inc. Tempe AZ).
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion: 1. Must be at least 18 years of age. 2. Patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB)/Medical Ethics Committee (MEC) of the respective clinical site. 3. Symptomatic patient as evidence by IC or CLI. 4. Patient has failed maximized medical treatment and exercise program. 5. Patient has a resting ABI \< 0.9 or an abnormal exercise ABI if resting ABI is normal.Patient with non-compressible arteries (ABI \> 1.2) must have a TBI \< 0.8. 6. Patient has a de novo or restenotic lesion(s) with \> 50% stenosis documented angiographically. 7. Patient agrees to return for all required clinical contacts following study enrollment. 8. Patient has no childbearing potential or has a negative pregnancy test within one week prior to the study procedure. Anatomical Inclusion: 1. Patient with any SFA lesion 2. At least one tibial vessel runoff with \< 50% stenosis 3. Lesion starts start at least 1 cm distal to the deep femoral artery 4. Lesion end at least 3 cm above the knee joint 5. Target vessel reference diameter is \> 3 mm & \< 6.5 mm
Exclusion criteria
Clinical exclusion: 1. Known allergic reaction to anesthesia not able to overcome by medication. 2. Known allergic reaction to contrast not able to overcome by medication. 3. Known history of intolerance to study medicating including ASA, clopidogrel, or ticlopidine. 4. Bleeding disorder or refuses blood transfusion. 5. Prior stenting or bypass of SFA (prior PTA is not an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement | 12 Month Post Operatively | Clinical Improvement is measured as at least 1 Rutherford category |
| Patency rate | 12 Month Post Operatively | Primary, primary assisted and secondary at 6, 12 month |
| Cost effectiveness | 12 Month Post Operatively | Cost Effectiveness factoring procedure and hospital admission costs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day operative mortality | 12 Month Post Operatively | — |
| Quality of Life improvement | 12 Month Post Operatively | Improvement of quality of life measured using VQL |
| Morbidity associated with both treatment modalities | 12 Month Post Operatively | — |
| Time to return to work and regular activities | 12 Month Post Operatively | — |
| Re-intervention rate | 12 Month Post Operatively | — |
| Technical success of both treatment modalities | 12 Month Post Operatively | — |
Countries
United States
Outcome results
None listed