NCT01609621

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Geographic Reach
3 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

May 16, 2012

Last Update Submit

November 16, 2020

Conditions

Peripheral Arterial DiseaseCritical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

  • Technical Success deeming tibial pedal arterial access

    1 - 4 hours post-procedure.

Study Arms (1)

Retrograde access

Device: Retrograde tibiopedal arterial access

Interventions

Retrograde tibiopedal arterial accessDEVICE

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.

Retrograde access

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patient will not sign the Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Interventional Technologies, LLC (Tucson Medical Center)

Tucson, Arizona, 85712, United States

Location

MedStar Health Research Institute (Washington Hospital Center)

Washington D.C., District of Columbia, 20010, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32216, United States

Location

University of Miami (Mount Sinai Hospital)

Miami, Florida, 33140, United States

Location

Terrebone Medical Center

Houma, Louisiana, 70360, United States

Location

Metro Heart and Vascular

Wyoming, Michigan, 49519, United States

Location

Rex Hospital, Inc

Raleigh, North Carolina, 27607, United States

Location

CAMC Health Education and Research Institute, Inc.

Charleston, West Virginia, 25304, United States

Location

Universit ts-Herzzentrum Freiburg - Bad Krozingen GmbH

Bad Krozingen, 79189, Germany

Location

Park-Krankenhaus Leipzig GmbH

Leipzig, 04289, Germany

Location

Casa Di Cura Abano Terme

Abano Terme, 35031, Italy

Location

Related Publications (1)

  • 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.

    PMID: 27558463DERIVED

MeSH Terms

Conditions

Peripheral Arterial DiseaseChronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Officials

  • Craig Walker, MD

    Terrebone General Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2012

First Posted

June 1, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2013

Study Completion

August 1, 2013

Last Updated

November 17, 2020

Record last verified: 2020-11

Locations

DE(2)US(8)IT(1)