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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-11-30

Brief Summary

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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

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Conditions

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Vascular Disease, Peripheral

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Endovascular Intervention

Peritoneal Lined Stent Endovascular Intervention

Intervention Type PROCEDURE

Eligibility Criteria

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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.)

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Timur Sarac, MD

Role: STUDY_DIRECTOR

PeriTec Bioscience Ltd

Locations

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Pontificia Universidad Catolica de Chile

Santiago, , Chile

Site Status RECRUITING

Countries

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Chile

Central Contacts

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Rajesh Khosla, MBA

Role: CONTACT

Phone: 216.444.1293

Email: [email protected]

Linda Modzelewski

Role: CONTACT

Phone: 216.444.5004

Email: [email protected]

Facility Contacts

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Albrecht Kramer, MD

Role: primary

References

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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. doi: 10.1583/05-1710R.1.

Reference Type BACKGROUND

PMID: 16643070 (View on PubMed)

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. doi: 10.1016/j.jvs.2004.11.033.