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

Vascular Disease, Peripheral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00542646
• Other study ID #: PB-PLS-2005-001
• Status: Recruiting
• Phase: Phase 0
• First received: October 10, 2007
• Last updated: November 27, 2007
• Start date: November 2006
• Est. completion date: November 2010

Study information

• Verified date: November 2007
• Source: PeriTec Biosciences Ltd.
• Contact: Rajesh Khosla, MBA
• Phone: 216.444.1293
• Email: rkhosla[@]peritecbio.com
• Is FDA regulated: No
• Health authority: Chile: Minstry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Disease, Peripheral
• Vascular Diseases

Intervention

Procedure:
• Endovascular Intervention
Peritoneal Lined Stent Endovascular Intervention

Locations

Country	Name	City	State
Chile	Pontificia Universidad Catolica de Chile	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
PeriTec Biosciences Ltd.

Country where clinical trial is conducted

Chile, 

References & Publications (2)

Carnevale K, Ouriel K, Gabriel Y, Clair D, Bena JF, Silva MB, Sarac TP. Biological coating for arterial stents: the next evolutionary change in stents. J Endovasc Ther. 2006 Apr;13(2):164-74. — View Citation

Sarac TP, Carnevale K, Smedira N, Tanquilut E, Augustinos P, Patel A, Naska T, Clair D, Ouriel K. In vivo and mechanical properties of peritoneum/fascia as a novel arterial substitute. J Vasc Surg. 2005 Mar;41(3):490-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Primary patency postprocedure and technical success Safety: Composite of major procedural adverse events		30 Days
Secondary	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