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

Cardiovascular Diseases Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05859503
• Other study ID #: PERCLOSE PROGLIDE
• Status: Recruiting
• Start date: May 16, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: May 2023
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: BRUNO GARCIA DEL BLANCO, PhD, MD
• Phone: 0034932746135
• Email: brunogb51[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• Closure Strategy with Perclose-Proglide system
Patients who have required Perclose-Proglide system in Percutaneous Interventional Procedure
• Closure Strategy with figure-of-8
Patients who have required the manual compression with figure-of-8 in Percutaneous Interventional Procedure

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall D'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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