NCT05220540

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

3 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

January 1, 2010

Completed
12.1 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

November 21, 2023

Status Verified

February 1, 2023

Enrollment Period

13.6 years

First QC Date

January 18, 2022

Last Update Submit

November 20, 2023

Conditions

Vascular Complications

Keywords

covered stentbleedingclosure devicepseudoaneurysmstenosisstent fracture

Outcome Measures

Primary Outcomes (3)

  • Primary patency rate

    Number of patent common femoral arteries at one year

    1 year

  • Reintervention rate

    Number of reinterventions on the treated vessels

    1 year

  • Amputation rate

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

    1 year

Secondary Outcomes (2)

  • Restenosis rate

    1 year

  • Walking disturbance rate

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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).

You may qualify if:

  • 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)

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

Szeged, Csongrád-Csanád, 6725, Hungary

Location

Gottsegen National Cardiovascular Center

Budapest, 1096, Hungary

Location

Semmelweis University Heart and Vascular Center

Budapest, 1122, Hungary

Location

Related Publications (11)

  • 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.

    PMID: 26680377BACKGROUND

  • 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.

    PMID: 28705072BACKGROUND

  • 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.

    PMID: 26314688BACKGROUND

  • 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.

    PMID: 21127366BACKGROUND

  • 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.

    PMID: 28616553BACKGROUND

  • 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.

    PMID: 24440678BACKGROUND

  • 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.

    PMID: 27561160BACKGROUND

  • 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.

    PMID: 30175119BACKGROUND

  • 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.

    PMID: 8456398BACKGROUND

  • 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.

    PMID: 20162284BACKGROUND

  • 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.

    PMID: 39518689DERIVED

MeSH Terms

Conditions

HemorrhageAneurysm, FalseConstriction, Pathologic

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesPathological Conditions, Anatomical

Study Officials

  • Csaba Csobay-Novák, MD, PhD

    Semmelweis University Heart and Vascular Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Noninvasive Imaging

Study Record Dates

First Submitted

January 18, 2022

First Posted

February 2, 2022

Study Start

January 1, 2010

Primary Completion

August 10, 2023

Study Completion

August 31, 2023

Last Updated

November 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

HU(3)