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Laser Atherectomy Versus Angioplasty for the Treatment of Critical Limb Ischemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Baylor Research Institute
Information provided by (Responsible Party):
Baylor Research Institute Identifier:
First received: April 13, 2012
Last updated: June 19, 2015
Last verified: June 2015
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 Intervention
Critical Limb Ischemia
Procedure: Angioplasty
Procedure: Laser atherectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Prospective Trial Comparing Laser Atherectomy to Angioplasty With/Without Stenting for Infrageniculate Peripheral Disease

Resource links provided by NLM:

Further study details as provided by Baylor Research Institute:

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

Estimated Enrollment: 200
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01579123

Contact: Martha Mueller, RN 214-820-7755
Contact: Tammy Fisher, RN 214-820-7221

United States, Texas
Baylor Jack and Jane Hamilton Heart Hospital Recruiting
Dallas, Texas, United States, 75226
Contact: Martha Mueller, RN    214-820-7755   
Contact: Tammy Fisher, MBA, RN    214-820-7221   
Sub-Investigator: Brad Grimsley, MD         
Sub-Investigator: Javier Vasquez, MD         
Baylor Regional Medical Center at Plano Recruiting
Plano, Texas, United States, 75093
Contact: Martha Mueller, RN    214-820-7755   
Contact: Tammy Fisher, RN    214-820-7221   
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Contact: Martha Mueller, RN    214-820-7755   
Contact: Tammy Fisher, RN    214-820-7221   
Sponsors and Collaborators
Baylor Research Institute
Principal Investigator: William Shutze, MD Baylor Jack and Jane Hamilton Heart Hospital
  More Information

Responsible Party: Baylor Research Institute Identifier: NCT01579123     History of Changes
Other Study ID Numbers: 012-010
Study First Received: April 13, 2012
Last Updated: June 19, 2015

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

Additional relevant MeSH terms:
Pathologic Processes processed this record on May 22, 2017