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

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ClinicalTrials.gov Identifier: NCT00542646
Recruitment Status : Unknown
Verified November 2007 by PeriTec Biosciences Ltd..
Recruitment status was:  Recruiting
First Posted : October 11, 2007
Last Update Posted : November 28, 2007
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Vascular Disease, Peripheral Procedure: Endovascular Intervention Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2006
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: Endovascular Intervention
    Peritoneal Lined Stent Endovascular Intervention


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

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00542646     History of Changes
Other Study ID Numbers: PB-PLS-2005-001
First Posted: October 11, 2007    Key Record Dates
Last Update Posted: November 28, 2007
Last Verified: November 2007

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