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

Early Phase 1

• Conditions: Vascular Disease, Peripheral

• Registration Number: NCT00542646
• Lead Sponsor: PeriTec Biosciences Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-10-10
• Study First Submitted QC: 2007-10-10
• Study First Posted: 2007-10-11
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-27
• Last Update Posted: 2007-11-28
• Study Completion: 2010-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy: Primary patency postprocedure and technical success Safety: Composite of major procedural adverse events	30 Days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pontificia Universidad Catolica de Chile; 🇨🇱 Santiago, Chile