Laser Atherectomy Versus Angioplasty for the Treatment of Critical Limb Ischemia
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| First Received Date ICMJE | April 13, 2012 | ||||||||
| Last Updated Date | February 5, 2013 | ||||||||
| Start Date ICMJE | February 2012 | ||||||||
| Estimated Primary Completion Date | February 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Outcome measure: difference in patency rates [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01579123 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Laser Atherectomy Versus Angioplasty for the Treatment of Critical Limb Ischemia | ||||||||
| Official Title ICMJE | Prospective Trial Comparing Laser Atherectomy to Angioplasty With/Without Stenting for Infrageniculate Peripheral Disease | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Condition ICMJE | Critical Limb Ischemia | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | February 2015 | ||||||||
| Estimated Primary Completion Date | February 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01579123 | ||||||||
| Other Study ID Numbers ICMJE | 012-010 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Baylor Research Institute | ||||||||
| Study Sponsor ICMJE | Baylor Research Institute | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Baylor Research Institute | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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