Cardiovascular DiseasesNCT05859503
A Comparison Study of the Perclose Proglide (TM) SMC System Versus Figure-of-8- Suture Technique for Closure of Large-bore Femoral Venous Access.
An observational study of Cardiovascular Diseases, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Closure Strategy with Perclose-Proglide system and Closure Strategy with figure-of-8
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 16 May 2023to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone interventional procedures and who have required the use of figure-of-8 suture versus Perclose-Proglide system closure
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Vall D'Hebron
Barcelona, 08035
About this study
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)
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Closure Strategy with Perclose-Proglide system, Closure Strategy with figure-of-8
- Keywords
- Femoral venous access closure techniques, Figure-of-8 suture,Perclose-Proglide system
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure Strategy with Perclose-Proglide systemOther
Patients who have required Perclose-Proglide system in Percutaneous Interventional Procedure
Closure Strategy with figure-of-8Other
Patients who have required the manual compression with figure-of-8 in Percutaneous Interventional Procedure
| Study group | Role | What they receive |
|---|---|---|
| Perclose-Proglide system | Not described Receives: Other: Closure Strategy with Perclose-Proglide system | |
| Figure-of-8 | Not described Receives: Other: Closure Strategy with figure-of-8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Major vascular complications
Incidence of patients with Major vascular complications
Measured: 30 days
Assessment of Major vascular complications
Incidence of patients with Major vascular complications
Measured: Discharge (assessed up to day 5)
Assessment of rebleeding
Incidence of patients with rebleeding
Measured: Discharge (assessed up to day 5)
Rebleeding
Incidence of patients with rebleeding
Measured: 30 days
Secondary outcomes (13)
Assessment of Death
Incidence of dead patients
Measured: Discharge (assessed up to day 5)
Assessment of Death
Incidence of dead patients
Measured: 30 days
Assessment of Death related to vascular access
Incidence of dead patients related to vascular access
Measured: 30 days
Assessment of Death related to vascular access
Incidence of dead patients related to vascular access
Measured: Discharge (assessed up to day 5)
Assessment of Hematoma
Incidence of patients with hematoma the venous puncture
Measured: 24 hours
Assessment of Hematoma Size
Area in cm of the hematoma at the venous puncture in patients with hematoma
Measured: 24 hours
Assessment of Vascular access point infection
Incidence of patients with infection in vascular access point
Measured: Discharge (assessed up to day 5)
Assessment of Vascular access point infection
Incidence of patients with infection in vascular access point
Measured: 30 days
Assessment of Urinary infections
Incidence of patients with urinary infection
Measured: 30 days
Assessment of Urinary infections
Incidence of patients with urinary infection
Measured: Discharge (assessed up to day 5)
Assessment of sitting-walking time
Time in hours between the patient sitting and walking after the vascular access
Measured: Discharge (assessed up to day 5)
Assessment of Technical success
Technical success when complete hemostasis is less than 1 minute after closure strategy performed
Measured: 1 minute after closure performed
Assessment of Clinical success
Technical success in the absence of events after closure strategy
Measured: Discharge (assessed up to day 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start16 May 2023
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859503
- Sponsor's protocol ID
- PERCLOSE PROGLIDE
- Status last verified
- May 2023
- First submitted
- 3 May 2023
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22431302Jensen 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.
PubMed 32308550Mohanty 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.
PubMed 30726903Pracon 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.
PubMed 28303670Geis 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.
PubMed 24694560Noori 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.
PubMed 30146036
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05859503
- Acronym / sponsor ID
- PERCLOSE PROGLIDE
- Conditions
- Cardiovascular Diseases
- Keywords
- Femoral venous access closure techniques, Figure-of-8 suture,Perclose-Proglide system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perclose-Proglide system | – | Other: Closure Strategy with Perclose-Proglide system |
| Figure-of-8 | – | Other: Closure Strategy with figure-of-8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone interventional procedures and who have required the use of figure-of-8 suture versus Perclose-Proglide system closure
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closure Strategy with Perclose-Proglide systemPatients who have required Perclose-Proglide system in Percutaneous Interventional Procedure | Other | Perclose-Proglide system |
| Closure Strategy with figure-of-8Patients who have required the manual compression with figure-of-8 in Percutaneous Interventional Procedure | Other | Figure-of-8 |
Primary outcome
Assessment of Major vascular complications
Time frame: 30 days
Incidence of patients with Major vascular complications
Assessment of Major vascular complications
Time frame: Discharge (assessed up to day 5)
Incidence of patients with Major vascular complications
Assessment of rebleeding
Time frame: Discharge (assessed up to day 5)
Incidence of patients with rebleeding
Rebleeding
Time frame: 30 days
Incidence of patients with rebleeding
13 secondary outcomes
Assessment of Death
Time frame: Discharge (assessed up to day 5)
Assessment of Death
Time frame: 30 days
Assessment of Death related to vascular access
Time frame: 30 days
Assessment of Death related to vascular access
Time frame: Discharge (assessed up to day 5)
Assessment of Hematoma
Time frame: 24 hours
Assessment of Hematoma Size
Time frame: 24 hours
Assessment of Vascular access point infection
Time frame: Discharge (assessed up to day 5)
Assessment of Vascular access point infection
Time frame: 30 days
Assessment of Urinary infections
Time frame: 30 days
Assessment of Urinary infections
Time frame: Discharge (assessed up to day 5)
Assessment of sitting-walking time
Time frame: Discharge (assessed up to day 5)
Assessment of Technical success
Time frame: 1 minute after closure performed
Assessment of Clinical success
Time frame: Discharge (assessed up to day 5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Background: PubMed 22431302Hamid 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.
- Background: PubMed 32308550Jensen 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.
- Background: PubMed 30726903Mohanty 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.
- Background: PubMed 28303670Pracon 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.
- Background: PubMed 24694560Geis 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.
- Background: PubMed 30146036Noori 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BRUNO GARCIA DEL BLANCO, PhD, MD (0034932746135, brunogb51@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Major vascular complications (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05859503, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.