Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions
This study is currently recruiting participants.
Verified December 2012 by Cook
Sponsor:
Cook
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01609621
First received: May 16, 2012
Last updated: December 24, 2012
Last verified: December 2012
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Purpose
The objective of this prospective, non-randomized, multicenter, post-market, observational study is to compile clinical data on percutaneous techniques used to obtain tibiopedal access and to cross infrainguinal arterial occlusions.
| Condition | Intervention |
|---|---|
|
Peripheral Arterial Disease, Critical Limb Ischemia |
Device: Retrograde tibiopedal arterial access |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions |
Resource links provided by NLM:
Further study details as provided by Cook:
Primary Outcome Measures:
- Technical Success deeming tibial pedal arterial access [ Time Frame: 1 - 4 hours post-procedure. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Retrograde access |
Device: Retrograde tibiopedal arterial access
Retrograde, percutaneous arterial access of vessels at or below the tibioperoneal trunk, using a 21 gage needle or micropuncture introducer set, to facilitate crossing and treatment (e.g., angioplasty, stenting, atherectomy) of occlusive arterial lesions in the lower limb.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients will be selected among those presenting with symptoms of peripheral arterial ischemic disease of the lower extremities and for whom endovascular intervention is deemed appropriate.
Criteria
Inclusion Criteria:
- Patient has a totally occluded infrainguinal artery, due to peripheral arterial atherosclerotic disease, for which a previous attempt to cross the occlusion using an antegrade approach was unsuccessful. For institutions where tibiopedal access is performed as a primary standard-of-care procedure, a prior unsuccessful antegrade approach attempt is not required.
Exclusion Criteria:
- Patient will not sign the Informed Consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609621
Contacts
| Contact: Beth Hess, PhD | 765-463-7537 |
Locations
| United States, Florida | |
| First Coast Cardiovascular Institute | Recruiting |
| Jacksonville, Florida, United States, 32216 | |
| Contact: Yazan Khatib, MD 904-493-3333 ykhatib@firstcoastcardio.com | |
| United States, Louisiana | |
| Terrebone Medical Center | Recruiting |
| Houma, Louisiana, United States, 70360 | |
| Contact: Craig Walker, MD 985-855-4841 drcrwalker@aol.com | |
| United States, Michigan | |
| Metro Heart and Vascular | Recruiting |
| Wyoming, Michigan, United States, 49519 | |
| Contact: Jihad Mustapha, MD 616-241-2333 | |
| United States, North Carolina | |
| Rex Hospital, Inc | Recruiting |
| Raleigh, North Carolina, United States, 27607 | |
| Contact: George L Adams, MD 919-784-5600 george.adams@rexhealth.com | |
Sponsors and Collaborators
Cook
Investigators
| Principal Investigator: | Craig Walker, MD | Terrebone General Medical Center |
More Information
No publications provided
| Responsible Party: | Cook |
| ClinicalTrials.gov Identifier: | NCT01609621 History of Changes |
| Other Study ID Numbers: | 11-008 |
| Study First Received: | May 16, 2012 |
| Last Updated: | December 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Ischemia Peripheral Arterial Disease Peripheral Vascular Diseases Pathologic Processes Atherosclerosis |
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013