Clinical Outcomes of Three Different Percutaneous Revascularization Strategies for the Treatment of Lifestyle Limiting Claudication: A Retrospective Analysis (FIX-IT Retro)
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | August 7, 2007 | ||||||||
| Last Updated Date | February 20, 2013 | ||||||||
| Start Date ICMJE | August 2007 | ||||||||
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00512720 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 | Clinical Outcomes of Three Different Percutaneous Revascularization Strategies for the Treatment of Lifestyle Limiting Claudication: A Retrospective Analysis | ||||||||
| Official Title ICMJE | Clinical Outcomes of Three Different Percutaneous Revascularization Strategies for the Treatment of Lifestyle Limiting Claudication: A Retrospective Analysis | ||||||||
| Brief Summary | To determine the effect of three different percutaneous revascularization strategies (Balloon Cryoplasty vs. Stent Placement vs. Atherectomy) in the treatment of lifestyle limiting lower extremity claudication |
||||||||
| Detailed Description | Endovascular revascularization of the superficial femoral artery (SFA) has become one of the most commonly performed endovascular procedures.The ability to offer the patient an alternative to surgical revascularization, limited by significant morbidity and mortality, with a same-day outpatient percutaneous procedure underlies the popularity of the endovascular approach. Although surgical bypass of the SFA remains the gold standard for revascularization, it is associated with significant morbidity and mortality.Comparative data between cryoplasty, angioplasty or stenting of the SFA will ultimately be required to provide more robust evidence of the efficacy of each mode of therapy.This registry is designed to determine the efficacy of three different percutaneous revascularization strategies (Cryoplasty vs. Stent Placement vs. Atherectomy) in the treatment of lifestyle limiting lower extremity claudication. |
||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: blood |
||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | male and female over the age of 18 who have had Three Different Percutaneous Revascularization Strategies |
||||||||
| Condition ICMJE | Peripheral Artery Disease | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 355 | ||||||||
| Completion Date | February 2010 | ||||||||
| Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00512720 | ||||||||
| Other Study ID Numbers ICMJE | 2007-174 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Jihad Mustapha, MD, Spectrum Health | ||||||||
| Study Sponsor ICMJE | Spectrum Health Hospitals | ||||||||
| Collaborators ICMJE | West Michigan Heart | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Spectrum Health Hospitals | ||||||||
| Verification Date | February 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||