A Comparison Study of the Perclose Proglide (TM) SMC System Versus Figure-of-8- Suture Technique for Closure of Large-bore Femoral Venous Access.

NCT05859503 | Unknown

• 1 other identifier: PERCLOSE PROGLIDE
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy and safety of two strategies for closing large caliber venous access in patients undergoing percutaneous procedures: compression with figure-of-8 suture versus closure with the Perclose-Proglide system.

Conditions

Cardiovascular Diseases

Keywords

Femoral venous access closure techniques; Figure-of-8 suture,Perclose-Proglide system

Outcome Measures

Primary Outcomes (4)

• Assessment of Major vascular complications

  Incidence of patients with Major vascular complications

  30 days

• Assessment of Major vascular complications

  Incidence of patients with Major vascular complications

  Discharge (assessed up to day 5)

• Assessment of rebleeding

  Incidence of patients with rebleeding

  Discharge (assessed up to day 5)

• Rebleeding

  Incidence of patients with rebleeding

  30 days

Secondary Outcomes (13)

• Assessment of Death

  Discharge (assessed up to day 5)

• Assessment of Death

  30 days

• Assessment of Death related to vascular access

  30 days

• Assessment of Death related to vascular access

  Discharge (assessed up to day 5)

• Assessment of Hematoma

  24 hours

Study Arms (2)

Perclose-Proglide system

Other: Closure Strategy with Perclose-Proglide system

Figure-of-8

Other: Closure Strategy with figure-of-8

Interventions

Closure Strategy with Perclose-Proglide system OTHER

Patients who have required Perclose-Proglide system in Percutaneous Interventional Procedure

Perclose-Proglide system

Closure Strategy with figure-of-8 OTHER

Patients who have required the manual compression with figure-of-8 in Percutaneous Interventional Procedure

Figure-of-8

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone interventional procedures and who have required the use of figure-of-8 suture versus Perclose-Proglide system closure

You may qualify if:

• Adult patients aged \> 18 years
• Patients who have undergone percutaneous interventional procedures
• Patients in whom the procedures have been performed with femoral venous access
• Patients who have required large caliber pods ≥ 14 French.

You may not qualify if:

• Patients who have required access with surgical exposure.
• Patients who have required ipsilateral arterial access with a large caliber ≥ 14 French
• Patients with previous vascular surgery.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

RECRUITING

Related Publications (6)

• Hamid T, Rajagopal R, Pius C, Clarke B, Mahadevan VS. Preclosure of large-sized venous access sites in adults undergoing transcatheter structural interventions. Catheter Cardiovasc Interv. 2013 Mar;81(4):586-90. doi: 10.1002/ccd.24358. Epub 2012 Nov 8.

  PMID: 22431302 BACKGROUND

• Jensen CJ, Schnur M, Lask S, Attanasio P, Gotzmann M, Kara K, Hanefeld C, Mugge A, Wutzler A. Feasibility of the Figure-of-8-Suture as Venous Closure in Interventional Electrophysiology: One Strategy for All? Int J Med Sci. 2020 Apr 6;17(7):965-969. doi: 10.7150/ijms.42593. eCollection 2020.

  PMID: 32308550 BACKGROUND

• Mohanty S, Trivedi C, Beheiry S, Al-Ahmad A, Horton R, Della Rocca DG, Gianni C, Gasperetti A, Abdul-Moheeth M, Turakhia M, Natale A. Venous access-site closure with vascular closure device vs. manual compression in patients undergoing catheter ablation or left atrial appendage occlusion under uninterrupted anticoagulation: a multicentre experience on efficacy and complications. Europace. 2019 Jul 1;21(7):1048-1054. doi: 10.1093/europace/euz004.

  PMID: 30726903 BACKGROUND

• Pracon R, Bangalore S, Henzel J, Cendrowska-Demkow I, Pregowska-Chwala B, Tarnowska A, Dzielinska Z, Chmielak Z, Witkowski A, Demkow M. A randomized comparison of modified subcutaneous "Z"-stitch versus manual compression to achieve hemostasis after large caliber femoral venous sheath removal. Catheter Cardiovasc Interv. 2018 Jan 1;91(1):105-112. doi: 10.1002/ccd.27003. Epub 2017 Mar 17.

  PMID: 28303670 BACKGROUND

• Geis NA, Pleger ST, Chorianopoulos E, Muller OJ, Katus HA, Bekeredjian R. Feasibility and clinical benefit of a suture-mediated closure device for femoral vein access after percutaneous edge-to-edge mitral valve repair. EuroIntervention. 2015 Mar;10(11):1346-53. doi: 10.4244/EIJV10I11A231.

  PMID: 24694560 BACKGROUND

• Noori VJ, Eldrup-Jorgensen J. A systematic review of vascular closure devices for femoral artery puncture sites. J Vasc Surg. 2018 Sep;68(3):887-899. doi: 10.1016/j.jvs.2018.05.019. Epub 2018 Jun 29.

  PMID: 30146036 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

BRUNO GARCIA DEL BLANCO, PhD, MD

CONTACT

0034932746135; brunogb51@gmail.com

MARIA ANGELES CARMONA

CONTACT

0034932746135; m.angeles.carmona@vhir.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 16, 2023
• Study Start: May 16, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

ES (1)