Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions (PFAST-CTOs)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

BridgePoint Medical

ClinicalTrials.gov Identifier:

NCT01246505

First received: November 19, 2010

Last updated: July 11, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 19, 2010

Last Updated Date

July 11, 2012

Start Date ^ICMJE

July 2011

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence of Patients with a Major Adverse Events (MAE) [ Time Frame: 30 Day ] [ Designated as safety issue: Yes ]
MAE is defined as death, major unplanned amputation, perforation requiring intervention, or target lesion revascularization due to complication.
Incidence of Intraprocedural Technical Success [ Time Frame: Intraprocedural (<24 hours) ] [ Designated as safety issue: No ]
Technical success is defined as the placement of a guidewire in the true lumen distal to the CTO

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01246505 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions

Official Title ^ICMJE

Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions

Brief Summary

Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Chronic Total Occlusion

Intervention ^ICMJE

Device: CTO Crossing and Percutaneous transluminal angioplasty

Crossing of the CTO with the BridgePoint Medical System and subsequent treatment of the CTO via PTA (specific devices to be used for PTA at investigators' discretion)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

105

Completion Date

January 2012

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

suitable candidate for non-emergent, peripheral angioplasty
documented de-novo or restenotic peripheral CTO lesion with TIMI 0 flow for at least 90 days and satisfactory distal vessel visualization (collateral supply)
limb ischemia or claudication, Rutherford class I-III (grade 1-5) caused by the occluded artery

Exclusion Criteria:

intolerance to aspirin or a neutropenic response to Ticlopidine or Clopidogrel
appearance of thrombus or intraluminal filling defects
peripheral intervention in the target limb within two weeks of the procedure
renal insufficiency (serum creatinine of > 2.3 mg/dl)
contraindication to a peripheral artery intervention
participation in another investigational protocol

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01246505

Other Study ID Numbers ^ICMJE

200-0012

Has Data Monitoring Committee

Yes

Responsible Party

BridgePoint Medical

Study Sponsor ^ICMJE

BridgePoint Medical

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

William A Gray, MD

Columbia University

Information Provided By

BridgePoint Medical

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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