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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: Closure Strategy with Perclose-Proglide system; Other: Closure Strategy with figure-of-8

Detailed Description

This is a retrospective observational study that aims to compare two strategies for closing large-caliber femoral venous access in patients who have undergone percutaneous procedures.

The study's goal is to determine if there are significant differences in terms of efficacy and safety between the two closure strategies. Figure-of-8 suture compression is a well-established technique that has been used for decades to close large-bore femoral venous access, while the Perclose-Proglide system is a relatively new medical device that could have great utility for the closure of large-bore femoral venous access. By comparing these two strategies, researchers hope to determine the safety and effectiveness of the Perclose-Proglide system for closing large-bore femoral venous access in patients undergoing percutaneous procedures.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: BRUNO GARCIA DEL BLANCO, PhD, MD; Phone Number: 0034932746135; Email: brunogb51@gmail.com
• Study Contact Backup: Name: MARIA ANGELES CARMONA; Phone Number: 0034932746135; Email: m.angeles.carmona@vhir.org

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

Patients will meet all inclusion criteria:

• 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.

Exclusion Criteria:

Patients must not meet any exclusion criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Perclose-Proglide system	Other: Closure Strategy with Perclose-Proglide system; Patients who have required Perclose-Proglide system in Percutaneous Interventional Procedure
Figure-of-8	Other: Closure Strategy with figure-of-8; Patients who have required the manual compression with figure-of-8 in Percutaneous Interventional Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Death	Incidence of dead patients	Discharge (assessed up to day 5)
Assessment of Death	Incidence of dead patients	30 days
Assessment of Death related to vascular access	Incidence of dead patients related to vascular access	30 days
Assessment of Death related to vascular access	Incidence of dead patients related to vascular access	Discharge (assessed up to day 5)
Assessment of Hematoma	Incidence of patients with hematoma the venous puncture	24 hours
Assessment of Hematoma Size	Area in cm of the hematoma at the venous puncture in patients with hematoma	24 hours
Assessment of Vascular access point infection	Incidence of patients with infection in vascular access point	Discharge (assessed up to day 5)
Assessment of Vascular access point infection	Incidence of patients with infection in vascular access point	30 days
Assessment of Urinary infections	Incidence of patients with urinary infection	30 days
Assessment of Urinary infections	Incidence of patients with urinary infection	Discharge (assessed up to day 5)
Assessment of sitting-walking time	Time in hours between the patient sitting and walking after the vascular access	Discharge (assessed up to day 5)
Assessment of Technical success	Technical success when complete hemostasis is less than 1 minute after closure strategy performed	1 minute after closure performed
Assessment of Clinical success	Technical success in the absence of events after closure strategy	Discharge (assessed up to day 5)

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: May 3, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Femoral venous access closure techniques; Figure-of-8 suture,Perclose-Proglide system
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: PERCLOSE PROGLIDE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No