Laser Atherectomy Versus Angioplasty for the Treatment of Critical Limb Ischemia

January 17, 2018 updated by: Baylor Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75226
        • Baylor Jack and Jane Hamilton Heart Hospital
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor Plano
      • Plano, Texas, United States, 75093
        • Baylor Regional Medical Center at Plano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Outcome measure: difference in patency rates
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor Research Institute

Investigators

  • Principal Investigator: William Shutze, MD, Baylor Jack and Jane Hamilton Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

September 26, 2016

Study Completion (Actual)

September 26, 2016

Study Registration Dates

First Submitted

April 13, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (Estimate)

April 17, 2012

Study Record Updates

Last Update Posted (Actual)

January 19, 2018

Last Update Submitted That Met QC Criteria

January 17, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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