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

November 27, 2007 updated by: PeriTec Biosciences Ltd.

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.

Study Overview

Status

Unknown

Conditions

Vascular Disease, Peripheral

Intervention / Treatment

Procedure: Endovascular Intervention

Study Type

Interventional

Enrollment (Anticipated)

Phase

Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Chile
- - Santiago, Chile
    - Recruiting
    - Pontificia Universidad Católica de Chile
    - Contact:
      
      Albrecht Kramer, MD
      
      Phone Number: 562.354.3233
      
      Email: kramer@med.puc.cl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

ADULT
OLDER_ADULT
CHILD

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy: Primary patency postprocedure and technical success Safety: Composite of major procedural adverse events Time Frame: 30 Days	30 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Primary Patency Primary Assisted Patency Secondary Patency Clinical Success Major Amputations Target Vessel Revascularization Target Lesion Revascularization Time Frame: 3 Months Intervals except for Target Lesion Revascularization at 12 months	3 Months Intervals except for Target Lesion Revascularization at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PeriTec Biosciences Ltd.

Investigators

Study Director: Timur Sarac, MD, PeriTec Bioscience Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (ANTICIPATED)

November 1, 2010

Study Registration Dates

First Submitted

October 10, 2007

First Submitted That Met QC Criteria