Vascular Disease, Peripheral
Conditions
Brief summary
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.
Interventions
PROCEDUREEndovascular Intervention
Peritoneal Lined Stent Endovascular Intervention
Sponsors
PeriTec Biosciences Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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 * Lesion of the superficial femoral artery with a short segment occlusion(\<5cm first two patients and \<10cm there on) or high grade (\>50%) stenosis * Target lesion 1 cm below profunda/superficial femoral artery origin and 3cm above knee joint * Angiographic evidence of a minimum of at least one tibial with continuous artery runoff to the ankle that does not require intervention * Guidewire has successfully traversed lesion and is within the true lumen of the distal vessel, and successful placement of 9 french(Fr) sheath
Exclusion criteria
* Untreated iliac artery in-flow limiting lesion * Significant proximal common femoral or superficial femoral artery disease above or below target lesion * Any previously treated superficial femoral artery lesion * Any previous stenting or surgery in the target vessel * Femoral or popliteal aneurysm * Non-Atherosclerotic disease resulting in occlusion (e.g. embolism, vasculitis,etc) * Serum creatinine \>2.5 mg/dl * Any previously known coagulation disorder, including hypercoagulability * Severe medical co-morbidities or other medical condition (for example untreated coronary heart disease and congestive heart failure, severe chronic obstructive pulmonary disease, metastasis malignance, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Primary patency postprocedure and technical success Safety: Composite of major procedural adverse events | 30 Days |
Secondary
| Measure | 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 |
Countries
Chile
Contacts
Primary ContactRajesh Khosla, MBA
Backup ContactLinda Modzelewski
Outcome results
None listed