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Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions

NCT ID: NCT01609621

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

199 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Arterial Disease Critical Limb Ischemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Retrograde access

Retrograde tibiopedal arterial access

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Craig Walker, MD

Role: PRINCIPAL_INVESTIGATOR

Terrebone General Medical Center

Locations

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Interventional Technologies, LLC (Tucson Medical Center)

Tucson, Arizona, United States

Site Status

MedStar Health Research Institute (Washington Hospital Center)

Washington D.C., District of Columbia, United States

Site Status

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Site Status

University of Miami (Mount Sinai Hospital)

Miami, Florida, United States

Site Status

Terrebone Medical Center

Houma, Louisiana, United States

Site Status

Metro Heart and Vascular

Wyoming, Michigan, United States

Site Status

Rex Hospital, Inc

Raleigh, North Carolina, United States

Site Status

CAMC Health Education and Research Institute, Inc.

Charleston, West Virginia, United States

Site Status

Universit ts-Herzzentrum Freiburg - Bad Krozingen GmbH

Bad Krozingen, , Germany

Site Status

Park-Krankenhaus Leipzig GmbH

Leipzig, , Germany

Site Status

Casa Di Cura Abano Terme

Abano Terme, , Italy

Site Status

Countries

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United States Germany Italy

References

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Walker CM, Mustapha J, Zeller T, Schmidt A, Montero-Baker M, Nanjundappa A, Manzi M, Palena LM, Bernardo N, Khatib Y, Beasley R, Leon L, Saab FA, Shields AR, Adams GL. Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions: A Prospective Multicenter Observational Study. J Endovasc Ther. 2016 Dec;23(6):839-846. doi: 10.1177/1526602816664768. Epub 2016 Aug 24.

Reference Type DERIVED
PMID: 27558463 (View on PubMed)

Other Identifiers

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11-008

Identifier Type: -

Identifier Source: org_study_id