Femoropopliteal Stenting Clinical Trial
— SFAOfficial title:
Optimal Stent Selection for the Femoropopliteal Artery
| Verified date | August 2023 |
| Source | University of Nebraska |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Angioplasty and stenting for atherosclerotic occlusive disease in the arteries supplying the legs (Peripheral Arterial Disease, PAD) is the most common endovascular procedure outside of the heart, but carries the highest rate of reconstruction failure. The underlying reasons for these poor results are not completely clear, but the main arterial segment within the leg, the femoropopliteal artery, appears to be significantly different from other peripheral arteries because the Superficial Femoral Artery (SFA) and Popliteal Artery (PA) that comprise the femoropopliteal artery (FPA) segment, undergo large deformations during flexion of the limb. We propose to build mathematical models of human FPAs repaired with several frequently used PAD stents. These mathematical models would be able to assess the mechanical stress in the stented SFA and PA associated with limb flexion and predict disease recurrence for arteries with different patient and lesion characteristics. Results of model predictions will be validated in patients with PAD stents who have received these stents as part of their standard of care.
| Status | Terminated |
| Enrollment | 5 |
| Est. completion date | April 16, 2021 |
| Est. primary completion date | April 16, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Subjects eligible for participating in this study are patients with severe PAD who have: 1. endovascular repair of their femoropopliteal artery 2. standard pre-operative contrast-enhanced thin-section CTA of the lower extremities 3. intraoperative angiograms and blood pressure measurements proximal and distal to the stent during the endovascular repair 4. no aneurysmal disease of the target femoropopliteal artery 5. no prior open or endovascular repair of the target femoropopliteal artery (patients with re-interventions are not eligible) 6. at least 2 out of 3 patent crural outflow vessels 7. life expectancy >6 months 8. no iodinated contrast allergy 9. creatinine less than 1.6 g/dL (unless on chronic dialysis, dialysis patients are eligible) 10. no orthopedic prostheses in the region of interest 11. ability to comply with 6-12-month follow-up contrast enhanced thin-section CTA Exclusion Criteria: 1. no endovascular repair of the femoropopliteal artery 2. endovascular or open re-intervention in the target limb 3. no pre-operative thin-section contrast-enhanced CTA of the target limb 4. no intraoperative angiogram or blood pressure measurements proximal and distal to the stent 5. aneurysmal disease of the target femoropopliteal artery 6. less than 2 patent crural outflow vessels 7. life expectancy = 6 months 8. iodinated contrast allergy 9. orthopedic prosthesis in the region of interest 10. creatinine greater than 1.6 g/dL (unless dialysis patient, chronic dialysis patients are eligible) 11. inability to comply with 6-12-month contrast-enhanced CTA follow-up requirement 12. patient belongs to vulnerable population, i.e. pregnant women, prisoners, institutionalized individuals |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Nebraska Medical Center | Omaha | Nebraska |
| Lead Sponsor | Collaborator |
|---|---|
| University of Nebraska | National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Radius of the femoropopliteal artery lumen | Radius of the femoropopliteal artery lumen will be measured using follow-up CTA to assess narrowing of the artery after stent implantation. | 6-12 months |