Peripheral Arterial DiseaseNCT01609621
Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions
An observational study of Peripheral Arterial Disease and Critical Limb Ischemia, run by Cook Group Incorporated at 11 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease, Critical Limb Ischemia
- What is being tested?
- Retrograde tibiopedal arterial access
- Type of treatment
- Medical device
- How many people
- 199 participants
- Where
- 11 sitesin 3 countries
- Study dates
- May 2012to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patient will not sign the Informed Consent
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
United States8 sites
CAMC Health Education and Research Institute, Inc.
Charleston, West Virginia, 25304
Terrebone Medical Center
Houma, Louisiana, 70360
First Coast Cardiovascular Institute
Jacksonville, Florida, 32216
University of Miami (Mount Sinai Hospital)
Miami, Florida, 33140
Rex Hospital, Inc
Raleigh, North Carolina, 27607
Interventional Technologies, LLC (Tucson Medical Center)
Tucson, Arizona, 85712
MedStar Health Research Institute (Washington Hospital Center)
Washington D.C., District of Columbia, 20010
Metro Heart and Vascular
Wyoming, Michigan, 49519
Germany2 sites
Universit ts-Herzzentrum Freiburg - Bad Krozingen GmbH
Bad Krozingen, 79189
Park-Krankenhaus Leipzig GmbH
Leipzig, 04289
About this study
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.
- Being tested
- Retrograde tibiopedal arterial access
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Retrograde access | Not described Receives: Device: Retrograde tibiopedal arterial access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success deeming tibial pedal arterial access
Measured: 1 - 4 hours post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Craig Walker, MD, Principal investigator, Terrebone General Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609621
- Sponsor's protocol ID
- 11-008
- Status last verified
- Nov 2020
- First submitted
- 16 May 2012
- Last updated
- 17 Nov 2020
- Results posted
- No
Publications
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.
PubMed 27558463
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions
- ClinicalTrials.gov ID
- NCT01609621
- Acronym / sponsor ID
- 11-008
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 1 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrograde access | – | Device: Retrograde tibiopedal arterial access |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient will not sign the Informed Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrograde tibiopedal arterial accessRetrograde, 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. | Device | Retrograde access |
Primary outcome
Technical Success deeming tibial pedal arterial access
Time frame: 1 - 4 hours post-procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Derived from this study: PubMed 27558463Walker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Walker, MD principal investigator
Terrebone General Medical Center
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Critical Limb Ischemia, run by Cook Group Incorporated at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success deeming tibial pedal arterial access (time frame: 1 - 4 hours post-procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01609621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.