Laser Atherectomy Versus Angioplasty for the Treatment of Critical Limb Ischemia
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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 |
- 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 |
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| Contact: Veronica Cedillo, MSN, RN-BC | 214-820-7755 | veronica.cedillo@baylorhealth.edu |
| Contact: Tammy Fisher, RN | 214-820-7221 | tammyfi@baylorhealth.edu |
| United States, Texas | |
| Baylor Jack and Jane Hamilton Heart Hospital | Recruiting |
| Dallas, Texas, United States, 75226 | |
| Contact: Veronica Cedillo, MSN, RN-BC 214-820-7755 veronica.cedillo@baylorhealth.edu | |
| Contact: Tammy Fisher, RN 214-820-7221 tammyfi@baylorhealth.edu | |
| Sub-Investigator: Christopher Busken, MD | |
| Sub-Investigator: Brad Grimsley, MD | |
| Sub-Investigator: Javier Vasquez, MD | |
| The Heart Hospital Baylor Plano | Recruiting |
| Plano, Texas, United States, 75093 | |
| Contact: Veronica Cedillo, MSN, RN-BC 214-820-7755 veronica.cedillo@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: Veronica Cedillo, MSN, RN-BC 214-820-7755 veronica.cedillo@baylorhealth.edu | |
| Contact: Tammy Fisher, RN 214-820-7221 tammy.fisher@baylorhealth.edu | |
| 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: | February 5, 2013 |
| 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 June 17, 2013