Vascular Access ComplicationsNCT05521100
Application of Vascular Closure Device in Transvenous Cardiac Intervention
A study testing Vascular closure device and figure eight stitch in people with Vascular Access Complications, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Comparison of safety and efficacy between the application of vascular closure device and conventional figure-of-eight suture in transvenous cardiac interventional surgery Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vascular Access Complications
- What is being tested?
- Vascular closure device and figure eight stitch
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2022to 1 Dec 2023
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving lower extremity venous intervention with a diameter of 12F or more
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Safety and Efficacy Between the Application of Vascular Closure Device and Conventional Figure-of-eight Suture in Transvenous Cardiac Interventional Surgery
Comparison of safety and efficacy between the application of vascular closure device and conventional figure-of-eight suture in transvenous cardiac interventional surgery
Read the detailed description
Comparison of safety and efficacy between the application of vascular closure device and conventional figure-of-eight suture in transvenous cardiac interventional surgery.From the operation success rate, postoperative bleeding, immobilization time, the rate of revisiting the doctor due to wound problems within 1 month, etc.
- Conditions
- Vascular Access Complications
- Being tested
- Vascular closure device, figure eight stitch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular closure deviceProcedure or surgery
Suture of lower extremity veins using the Proglide Vascular Closure Device
figure eight stitchProcedure or surgery
Vascular Sutures for Transvenous Cardiac Intervention Using Conventional Figure-8 Sutures
| Study group | Role | What they receive |
|---|---|---|
| Proglide group | Experimental | Vascular Sutures for Transvenous Cardiac Interventions Using Proglide Receives: Procedure: Vascular closure device |
| figure eight stitch | Active comparator | Vascular Sutures for Transvenous Cardiac Intervention Using Conventional Figure-8 Sutures Receives: Procedure: figure eight stitch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular bleeding event rate
Proportion of bleeding after two methods of vascular suturing
Measured: 1month
Secondary outcomes (1)
bed braking time
Postoperative bed rest time
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start30 Sep 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access ComplicationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yawei Xu, PhD, Study chair, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521100
- Sponsor's protocol ID
- NSH-ACT
- Status last verified
- Sep 2022
- First submitted
- 29 Aug 2022
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Efficacy Between the Application of Vascular Closure Device and Conventional Figure-of-eight Suture in Transvenous Cardiac Interventional Surgery
- ClinicalTrials.gov ID
- NCT05521100
- Acronym / sponsor ID
- NSH-ACT
- Conditions
- Vascular Access Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 30 Aug 2022 (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.
Comparison of safety and efficacy between the application of vascular closure device and conventional figure-of-eight suture in transvenous cardiac interventional surgery
Detailed description
Comparison of safety and efficacy between the application of vascular closure device and conventional figure-of-eight suture in transvenous cardiac interventional surgery.From the operation success rate, postoperative bleeding, immobilization time, the rate of revisiting the doctor due to wound problems within 1 month, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proglide group | Experimental | Procedure: Vascular closure deviceVascular Sutures for Transvenous Cardiac Interventions Using Proglide |
| figure eight stitch | Active comparator | Procedure: figure eight stitchVascular Sutures for Transvenous Cardiac Intervention Using Conventional Figure-8 Sutures |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients receiving lower extremity venous intervention with a diameter of 12F or more
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Vascular closure deviceSuture of lower extremity veins using the Proglide Vascular Closure Device | Procedure or surgery | Proglide group |
| figure eight stitchVascular Sutures for Transvenous Cardiac Intervention Using Conventional Figure-8 Sutures | Procedure or surgery | figure eight stitch |
Primary outcome
Vascular bleeding event rate
Time frame: 1month
Proportion of bleeding after two methods of vascular suturing
1 secondary outcome
bed braking time
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Yawei Xu, PhD study chair
Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular closure device and figure eight stitch in people with Vascular Access Complications, run by Shanghai 10th People's Hospital at 1 site in China.
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 1 inclusion and 1 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 27 Sep 2022. 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 China. 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 DONGDONG ZHAO, M.D. (+86 15000420881, zhaodd@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular bleeding event rate (time frame: 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2022.