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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by PeriTec Biosciences Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
PeriTec Biosciences Ltd.
ClinicalTrials.gov Identifier:
NCT00542646
First received: October 10, 2007
Last updated: November 27, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Vascular Disease, Peripheral
Procedure: Endovascular Intervention
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate the Safety and Preliminary Efficacy of the Peritec Peritoneal Lined Stent and Delivery System

Resource links provided by NLM:


Further study details as provided by PeriTec Biosciences Ltd.:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 45
Study Start Date: November 2006
Estimated Study Completion Date: November 2010
Intervention Details:
    Procedure: Endovascular Intervention
    Peritoneal Lined Stent Endovascular Intervention
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542646

Contacts
Contact: Rajesh Khosla, MBA 216.444.1293 rkhosla@peritecbio.com
Contact: Linda Modzelewski 216.444.5004 lm@peritecbio.com

Locations
Chile
Pontificia Universidad Catolica de Chile Recruiting
Santiago, Chile
Contact: Albrecht Kramer, MD    562.354.3233    kramer@med.puc.cl   
Sponsors and Collaborators
PeriTec Biosciences Ltd.
Investigators
Study Director: Timur Sarac, MD PeriTec Bioscience Ltd
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00542646     History of Changes
Other Study ID Numbers: PB-PLS-2005-001
Study First Received: October 10, 2007
Last Updated: November 27, 2007
Health Authority: Chile: Minstry of Health

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 26, 2014