Clinical trial NCT05859503: A Comparison Study of the Perclose Proglide (TM) SMC System Versus Figure-of-8- Suture Technique for Closure of Large-bore Femoral Venous Access.
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Keywords: Femoral venous access closure techniques
Figure-of-8 suture,Perclose-Proglide system
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Major vascular complications
timeFrame: 30 days
measure: Assessment of Major vascular complications
timeFrame: Discharge (assessed up to day 5)
measure: Assessment of rebleeding
timeFrame: Discharge (assessed up to day 5)
measure: Rebleeding
timeFrame: 30 days
Secondary outcomes:
measure: Assessment of Death
timeFrame: Discharge (assessed up to day 5)
measure: Assessment of Death
timeFrame: 30 days
measure: Assessment of Death related to vascular access
timeFrame: 30 days
measure: Assessment of Death related to vascular access
timeFrame: Discharge (assessed up to day 5)
measure: Assessment of Hematoma
timeFrame: 24 hours
measure: Assessment of Hematoma Size
timeFrame: 24 hours
measure: Assessment of Vascular access point infection
timeFrame: Discharge (assessed up to day 5)
measure: Assessment of Vascular access point infection
timeFrame: 30 days
measure: Assessment of Urinary infections
timeFrame: 30 days
measure: Assessment of Urinary infections
timeFrame: Discharge (assessed up to day 5)
measure: Assessment of sitting-walking time
timeFrame: Discharge (assessed up to day 5)
measure: Assessment of Technical success
timeFrame: 1 minute after closure performed
measure: Assessment of Clinical success
timeFrame: Discharge (assessed up to day 5)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
Study officials:
References:
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.
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.
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.
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.
citation: 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.
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.