Pilot Study to Evaluate the Safety and Preliminary Efficacy of the Peritec Peritoneal Lined Stent and Delivery System

PeriTec Biosciences

Status and phase

Unknown

Early Phase 1

Conditions

Vascular Disease, Peripheral

Treatments

Procedure: Endovascular Intervention

Study type

Interventional

Funder types

Industry

Identifiers

NCT00542646

PB-PLS-2005-001

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.)