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Vascular ComplicationsBEST-CFANCT05220540

Retrospective Analysis of Balloon Expandable Covered Stenting in the Common Femoral Artery

An observational study of Vascular Complications, run by Semmelweis University Heart and Vascular Center at 3 sites in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate the safety and efficacy of balloon expandable covered stenting of access complications, stenoses or pseudoaneurysms of the common femoral access. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vascular Complications
How many people
24 participants
Where
3 sitesHungary
Study dates
1 Jan 2010to 31 Aug 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients undergoing either transcathether aortic valve repair (TAVR), endovascular aortic repair (EVAR) or thoracic endovascular aortic repair (TEVAR) via percutaneous femoral access resulting in access site complication, or patients who undergo endovascular therapy of common femoral artery disease, managed by balloon-expandable covered stent(s).

Who may be able to join

  • over 18 years of age
  • intervention from the left or right common femoral artery
  • access complication treated by balloon expandable covered stent(s) or common femoral artery disease treated by balloon-expandable covered stent(s)

Who cannot join

  • none

Trial locations and contacts

3 sites in 1 country.

Hungary3 sites

  • Gottsegen National Cardiovascular Center

    Budapest, 1096

  • Semmelweis University Heart and Vascular Center

    Budapest, 1122

  • University of Szeged, Albert Szent-Györgyi Health Center, Second Department of Medicine and Cardiology Centre

    Szeged, Csongrád-Csanád, 6725

Other trials in Hungary

About this study

The aim of this study is to evaluate the safety and efficacy of balloon expandable covered stenting of access complications, stenoses or pseudoaneurysms of the common femoral access.

Read the detailed description

In the past decades, there has been a paradigm shift in the field of vascular surgery, with endovascular interventions replacing traditional open surgical procedures on an increasing scale. Most of these interventions are performed via the femoral artery. Even with modern percutaneous vascular closure devices, interventional laboratories report a high incidence of vascular complications, most commonly bleeding. Interventional procedures are gaining ground as an alternative to surgery. Having regard to the fact that femoral arteries are in constant motion due to their location and are subject to intense bending forces, the long-term durability of stents has been questioned in the absence of long-term follow-up data. There is currently no broad consensus on the strategy of care for vascular complications, and overall the decision is left to the discretion of the interventionalist, largely determined by the available local resources and infrastructure. The use of covered stents is an option for endovascular treatment of the complications: the self expanding nitinol framed stent graft with polytetrafluoroethylene (PTFE) coating and the cobalt-chrome framed, also PTFE coated balloon expandable stent. The main aim of this research is to analyse the short- and long-term outcome of these alternatives.

Keywords
covered stent, bleeding, closure device, pseudoaneurysm, stenosis, stent fracture
Medical subject headings
Hemorrhage, Aneurysm, False, Constriction, Pathologic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary patency rate

    Number of patent common femoral arteries at one year

    Measured: 1 year

  2. Reintervention rate

    Number of reinterventions on the treated vessels

    Measured: 1 year

  3. Amputation rate

    Number of amputations at the side of the treated common femoral artery

    Measured: 1 year

Secondary outcomes (2)

  1. Restenosis rate

    Number of significant (peak systolic velocity ratio > 2,4) restenoses found at one year

    Measured: 1 year

  2. Walking disturbance rate

    Number of any new onset walking impairment

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2022
  2. Study start1 Jan 2010
  3. Primary completion10 Aug 2023
  4. Study completion31 Aug 2023

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05220540
Sponsor's protocol ID
AFC2022
Acronym
BEST-CFA
Status last verified
Feb 2023
First submitted
18 Jan 2022
Last updated
21 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cox T, Blair L, Huntington C, Lincourt A, Sing R, Heniford BT. Systematic Review of Randomized Controlled Trials Comparing Manual Compression to Vascular Closure Devices for Diagnostic and Therapeutic Arterial Procedures. Surg Technol Int. 2015 Nov;27:32-44.

    PubMed 26680377

  • Heger T, Strauss S, Blessing E, Andrassy M, Erbel C, Muller OJ, Chorianopoulos E, Pleger S, Leuschner F, Korosoglou G, Bekeredjian R, Katus HA, Vogel B. Short and long-term results after endovascular management of vascular complications during transfemoral aortic valve implantation. Acta Cardiol. 2017 Aug;72(4):474-482. doi: 10.1080/00015385.2017.1335455. Epub 2017 Jul 14.

    PubMed 28705072

  • Barbash IM, Barbanti M, Webb J, Molina-Martin De Nicolas J, Abramowitz Y, Latib A, Nguyen C, Deuschl F, Segev A, Sideris K, Buccheri S, Simonato M, Rosa FD, Tamburino C, Jilaihawi H, Miyazaki T, Himbert D, Schofer N, Guetta V, Bleiziffer S, Tchetche D, Imme S, Makkar RR, Vahanian A, Treede H, Lange R, Colombo A, Dvir D. Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation. Eur Heart J. 2015 Dec 14;36(47):3370-9. doi: 10.1093/eurheartj/ehv417. Epub 2015 Aug 26.

    PubMed 26314688

  • Schwartz BG, Burstein S, Economides C, Kloner RA, Shavelle DM, Mayeda GS. Review of vascular closure devices. J Invasive Cardiol. 2010 Dec;22(12):599-607.

    PubMed 21127366

  • Sekhar A, Sutton BS, Raheja P, Mohsen A, Anggelis E, Anggelis CN, Keith MC, Dawn B, Straton S, Flaherty MP. Femoral arterial closure using ProGlide(R) is more efficacious and cost-effective when ambulating early following cardiac catheterization. Int J Cardiol Heart Vasc. 2016 Oct 11;13:6-13. doi: 10.1016/j.ijcha.2016.09.002. eCollection 2016 Dec.

    PubMed 28616553

  • Nelson PR, Kracjer Z, Kansal N, Rao V, Bianchi C, Hashemi H, Jones P, Bacharach JM. A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial). J Vasc Surg. 2014 May;59(5):1181-93. doi: 10.1016/j.jvs.2013.10.101. Epub 2014 Jan 17.

    PubMed 24440678

  • Seeger J, Gonska B, Rodewald C, Rottbauer W, Wohrle J. Impact of suture mediated femoral access site closure with the Prostar XL compared to the ProGlide system on outcome in transfemoral aortic valve implantation. Int J Cardiol. 2016 Nov 15;223:564-567. doi: 10.1016/j.ijcard.2016.08.193. Epub 2016 Aug 17.

    PubMed 27561160

  • Durmus G, Belen E, Bayyigit A, Can MM. Comparison of Complication and Success Rates of ProGlide Closure Device in Patients Undergoing TAVI and Endovascular Aneurysm Repair. Biomed Res Int. 2018 Aug 9;2018:2687862. doi: 10.1155/2018/2687862. eCollection 2018.

    PubMed 30175119

  • Franco CD, Goldsmith J, Veith FJ, Calligaro KD, Gupta SK, Wengerter KR. Management of arterial injuries produced by percutaneous femoral procedures. Surgery. 1993 Apr;113(4):419-25.

    PubMed 8456398

  • Tsetis D. Endovascular treatment of complications of femoral arterial access. Cardiovasc Intervent Radiol. 2010 Jun;33(3):457-68. doi: 10.1007/s00270-010-9820-3. Epub 2010 Feb 17.

    PubMed 20162284

  • Szentivanyi A, Borzsak S, Suvegh A, Berczi A, Szucsborus T, Ruzsa Z, Fontos G, Szalay CI, Papp R, Molnar L, Csobay-Novak C. Midterm Outcome of Balloon-Expandable Covered Stenting of Femoral Access Site Complications. J Clin Med. 2024 Oct 31;13(21):6550. doi: 10.3390/jcm13216550.

    PubMed 39518689

Questions about this trial

What is this clinical trial studying?

An observational study of Vascular Complications, run by Semmelweis University Heart and Vascular Center at 3 sites in Hungary.

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 3 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 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Hungary. 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?

Primary patency rate (time frame: 1 year). The study lists 3 primary outcomes in all. 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 NCT05220540, which also lists 11 linked publications.

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 21 Nov 2023.

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