Vascular Complications Clinical Trial
— BEST-CFAOfficial title:
Retrospective Analysis of Balloon Expandable Covered Stenting in the Common Femoral Artery
NCT number | NCT05220540 |
Other study ID # | AFC2022 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2010 |
Est. completion date | August 31, 2023 |
Verified date | February 2023 |
Source | Semmelweis University Heart and Vascular Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | August 31, 2023 |
Est. primary completion date | August 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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) Exclusion criteria: - none |
Country | Name | City | State |
---|---|---|---|
Hungary | Gottsegen National Cardiovascular Center | Budapest | |
Hungary | Semmelweis University Heart and Vascular Center | Budapest | |
Hungary | University of Szeged, Albert Szent-Györgyi Health Center, Second Department of Medicine and Cardiology Centre | Szeged | Csongrád-Csanád |
Lead Sponsor | Collaborator |
---|---|
Semmelweis University Heart and Vascular Center |
Hungary,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary patency rate | Number of patent common femoral arteries at one year | 1 year | |
Primary | Reintervention rate | Number of reinterventions on the treated vessels | 1 year | |
Primary | Amputation rate | Number of amputations at the side of the treated common femoral artery | 1 year | |
Secondary | Restenosis rate | Number of significant (peak systolic velocity ratio > 2,4) restenoses found at one year | 1 year | |
Secondary | Walking disturbance rate | Number of any new onset walking impairment | 1 year |
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