Laser Atherectomy Versus Angioplasty for the Treatment of Critical Limb Ischemia

NCT01579123 | Completed DMC

• 1 other identifier: 012-010
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Critical Limb Ischemia

Keywords

Laser atherectomy; Critical Limb Ischemia; Angioplasty

Outcome Measures

Primary Outcomes (1)

• Outcome measure: difference in patency rates

  one year

Study Arms (2)

Laser atherectomy

ACTIVE COMPARATOR

Procedure: Laser atherectomy

Angioplasty

ACTIVE COMPARATOR

Procedure: Angioplasty

Interventions

Angioplasty PROCEDURE

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.

Angioplasty

Laser atherectomy PROCEDURE

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.

Laser atherectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (3)

Baylor Jack and Jane Hamilton Heart Hospital

Dallas, Texas, 75226, United States

Location

Baylor Regional Medical Center at Plano

Plano, Texas, 75093, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• William Shutze, MD

  Baylor Jack and Jane Hamilton Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 17, 2012
• Study Start: February 1, 2012
• Primary Completion: September 26, 2016
• Study Completion: September 26, 2016
• Last Updated: January 19, 2018

Record last verified: 2018-01

Locations

US (3)