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Laser Atherectomy Versus Angioplasty for the Treatment of Critical Limb Ischemia

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ClinicalTrials.gov Identifier: NCT01579123
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment
Critical Limb Ischemia Procedure: Angioplasty Procedure: Laser atherectomy

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Trial Comparing Laser Atherectomy to Angioplasty With/Without Stenting for Infrageniculate Peripheral Disease
Study Start Date : February 2012
Primary Completion Date : September 26, 2016
Study Completion Date : September 26, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Laser atherectomy 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: Angioplasty 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.



Primary Outcome Measures :
  1. Outcome measure: difference in patency rates [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579123


Locations
United States, Texas
Baylor Jack and Jane Hamilton Heart Hospital
Dallas, Texas, United States, 75226
Baylor Regional Medical Center at Plano
Plano, Texas, United States, 75093
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: William Shutze, MD Baylor Jack and Jane Hamilton Heart Hospital

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01579123     History of Changes
Other Study ID Numbers: 012-010
First Posted: April 17, 2012    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Keywords provided by Baylor Research Institute:
Laser atherectomy
Critical Limb Ischemia
Angioplasty

Additional relevant MeSH terms:
Ischemia
Pathologic Processes