Laser Atherectomy Versus Angioplasty for the Treatment of Critical Limb Ischemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Baylor Research Institute
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01579123
First received: April 13, 2012
Last updated: March 21, 2014
Last verified: March 2014

April 13, 2012
March 21, 2014
February 2012
February 2015   (final data collection date for primary outcome measure)
Outcome measure: difference in patency rates [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01579123 on ClinicalTrials.gov Archive Site
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Not Provided
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Laser Atherectomy Versus Angioplasty for the Treatment of Critical Limb Ischemia
Prospective Trial Comparing Laser Atherectomy to Angioplasty With/Without Stenting for Infrageniculate Peripheral Disease

The reason the investigators are doing this study is to compare the results of laser atherectomy versus angioplasty with or without the placement of a stent in the artery. A stent is a metal tube used to open up narrow arteries in the body.

People with peripheral artery disease that has severely reduced blood flow in their lower leg are usually treated with surgical bypass. This condition is known as Critical Limb Ischemia or CLI. Over the last decade, advances in techniques and tools have allowed surgeons to more aggressively treat complex cases. Studies have shown successful treatment of CLI with endovascular techniques (less invasive surgical procedures through a small incision for the treatment of vascular disease), including laser atherectomy and angioplasty. Surgical guidelines are not clear as to the best procedure to use for CLI. To the best of our knowledge, a study comparing laser atherectomy and angioplasty has not been done. Laser atherectomy works by releasing ultraviolet light which is absorbed by the plaque in the arteries. This will then get rid of the plaque. Angioplasty is a procedure used to open blocked or narrowed arteries. Currently, it is not known if laser atherectomy has better results than angioplasty.

Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Critical Limb Ischemia
  • Procedure: Angioplasty
    With angioplasty, a catheter is guided to the portion of the artery that is narrowed or blocked off. A balloon that is attached to the end of the catheter will be inflated which dilates or expands the artery in the area where the narrowing or blockage is located. Based on the angiogram and extent of disease, the physician may place a stent (small mesh tube that is used to treat narrow or weak arteries in the body) during the angioplasty.
  • Procedure: Laser atherectomy
    Laser atherectomy uses a catheter that emits high energy light (laser) to unblock the artery. The catheter is moved through the artery until it reaches the blockage. Laser energy is used to essentially vaporize the blockage inside the vessel.
  • Active Comparator: Laser atherectomy
    Intervention: Procedure: Laser atherectomy
  • Active Comparator: Angioplasty
    Intervention: Procedure: Angioplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
February 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age and older
  • Male or female (non-pregnant females)
  • Patients with peripheral artery disease that has progressed to critical limb ischemia (CLI)
  • Patients undergoing angiography with possible intervention for Rutherford Class 4-6 limb ischemia that may benefit from revascularization
Both
18 Years and older
No
Contact: Martha Mueller, RN 214-820-7755 martha.mueller@baylorhealth.edu
Contact: Tammy Fisher, RN 214-820-7221 tammyfi@baylorhealth.edu
United States
 
NCT01579123
012-010
Yes
Baylor Research Institute
Baylor Research Institute
Not Provided
Principal Investigator: William Shutze, MD Baylor Jack and Jane Hamilton Heart Hospital
Baylor Research Institute
March 2014

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