Laser Atherectomy Versus Angioplasty for the Treatment of Critical Limb Ischemia

Critical Limb Ischemia Clinical Trial

Official title:

Prospective Trial Comparing Laser Atherectomy to Angioplasty With/Without Stenting for Infrageniculate Peripheral Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579123
• Other study ID #: 012-010
• Status: Completed
• Phase: N/A
• First received: April 13, 2012
• Last updated: January 17, 2018
• Start date: February 2012
• Est. completion date: September 26, 2016

Study information

• Verified date: January 2018
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 26, 2016
• Est. primary completion date: September 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Baylor Jack and Jane Hamilton Heart Hospital	Dallas	Texas
United States	Baylor Regional Medical Center at Plano	Plano	Texas
United States	The Heart Hospital Baylor Plano	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome measure: difference in patency rates		one year