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The occurrence of Peripheral Vascular Disease has been increasing which includes the large artery in the upper leg called Superficial Femoral Artery (SFA). The Peritoneal Lined Stent has been developed as a new method for treating narrowed area in the SFA. This research study will determine the safety and effectiveness of the Peritoneal Lined Stent in keeping th Superficial Femoral Artery open and allowing blood to flow in the leg.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular Intervention | Procedure | Peritoneal Lined Stent Endovascular Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Primary patency postprocedure and technical success Safety: Composite of major procedural adverse events | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency Primary Assisted Patency Secondary Patency Clinical Success Major Amputations Target Vessel Revascularization Target Lesion Revascularization | 3 Months Intervals except for Target Lesion Revascularization at 12 months |
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Inclusion Criteria:
Patient with claudication or ischemic rest pain(Rutherford Categories 2-4)
The angiogram will need to have been performed confirming superficial femoral artery short segment occlusion(<5cm first two patients and <10cm there on) or high grade(>50%)stenosis
Patient has a signed and dated informed consent
Patient has a resting ABI <0.9 or an abnormal exercise ABI if resting ABI is normal. Patients with incompressible arteries (ABI >1.2) must have TBI <0.8
Life expectancy greater than one year
The ability to comply with protocol follow up requirements and required testing
Angiographic lesion requirements assessed at time of procedure
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rajesh Khosla, MBA | Contact | 216.444.1293 | rkhosla@peritecbio.com | |
| Linda Modzelewski | Contact | 216.444.5004 | lm@peritecbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Timur Sarac, MD | PeriTec Bioscience Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pontificia Universidad Catolica de Chile | Recruiting | Santiago | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16643070 | Background | Carnevale K, Ouriel K, Gabriel Y, Clair D, Bena JF, Silva MB, Sarac TP. Biological coating for arterial stents: the next evolutionary change in stents. J Endovasc Ther. 2006 Apr;13(2):164-74. doi: 10.1583/05-1710R.1. | |
| 15838485 | Background | Sarac TP, Carnevale K, Smedira N, Tanquilut E, Augustinos P, Patel A, Naska T, Clair D, Ouriel K. In vivo and mechanical properties of peritoneum/fascia as a novel arterial substitute. J Vasc Surg. 2005 Mar;41(3):490-7. doi: 10.1016/j.jvs.2004.11.033. |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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