NCT00542646

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Nov 2006

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2007

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

November 28, 2007

Status Verified

November 1, 2007

First QC Date

October 10, 2007

Last Update Submit

November 27, 2007

Conditions

Vascular Disease, Peripheral

Outcome Measures

Primary Outcomes (1)

  • Efficacy: Primary patency postprocedure and technical success Safety: Composite of major procedural adverse events

    30 Days

Secondary Outcomes (1)

  • 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

Interventions

Endovascular InterventionPROCEDURE

Peritoneal Lined Stent Endovascular Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontificia Universidad Catolica de Chile

Santiago, Chile

RECRUITING

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

    PMID: 16643070BACKGROUND

  • 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.

    PMID: 15838485BACKGROUND

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Timur Sarac, MD

    PeriTec Bioscience Ltd

    STUDY DIRECTOR

Central Study Contacts

Rajesh Khosla, MBA

CONTACT

216.444.1293rkhosla@peritecbio.com

Linda Modzelewski

CONTACT

216.444.5004lm@peritecbio.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 10, 2007

First Posted

October 11, 2007

Study Start

November 1, 2006

Study Completion

November 1, 2010

Last Updated

November 28, 2007

Record last verified: 2007-11

Locations

CL(1)