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OpenTrials
Completed

NCT Number: NCT01246505

Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions

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

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Key information

Conditions

Chronic Total Occlusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. Luke's Medical Center, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CTO Crossing and Percutaneous transluminal angioplasty

Device

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)

Primary outcomes

  1. Incidence of Patients with a Major Adverse Events (MAE)

    Time frame: 30 Day

    MAE is defined as death, major unplanned amputation, perforation requiring intervention, or target lesion revascularization due to complication.

  2. Incidence of Intraprocedural Technical Success

    Time frame: Intraprocedural (<24 hours)

    Technical success is defined as the placement of a guidewire in the true lumen distal to the CTO

Sponsors and collaborators

Lead sponsor

BridgePoint Medical

Industry

Registry information

Acronym: PFAST-CTOs

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Nov 23, 2010
Registry last updated
Jul 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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