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

Vascular Complications Clinical Trial

— BEST-CFA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05220540
• Other study ID #: AFC2022
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2023
• Source: Semmelweis University Heart and Vascular Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Vascular Complications

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University Heart and Vascular Center

Country where clinical trial is conducted

Hungary, 

References & Publications (10)

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

Outcome

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