Trial record 3 of 213 for:    Open Studies | angioplasty

Laser Atherectomy Versus Angioplasty for the Treatment of Critical Limb Ischemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Baylor Research Institute
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01579123
First received: April 13, 2012
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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 (Subject)
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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: NCT01579123

Contacts
Contact: Martha Mueller, RN 214-820-7755 martha.mueller@baylorhealth.edu
Contact: Tammy Fisher, RN 214-820-7221 tammyfi@baylorhealth.edu

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

No publications provided

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01579123     History of Changes
Other Study ID Numbers: 012-010
Study First Received: April 13, 2012
Last Updated: March 21, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014