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CatheterizationNCT05317533

Prevalence of Distal Radial Artery Occlusion in Cardiovascular Catheterization Via Distal Radial Access

An observational study of Catheterization and Complications, run by Wujin People's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Explore the prevalence of distal radial artery occlusion after cardiac catheterization via distal radial artery and the risk factors Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
cardiac catheterization via distal radial artery
Type of treatment
Surgery or procedure
How many people
805 participants
Where
1 siteChina
Study dates
1 Mar 2022to 18 Dec 2023
How long will I take part?
3 Months
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 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The subjects consist of patients who present to the cardiac catheterization laboratory for an angiogram or percutaneous intervention for the first time.

Who may be able to join

  • Age ≥ 18 years;
  • Palpable distal radial artery

Who cannot join

  • Age ≥ 90years;
  • Height≥ 185cm;
  • Cardiogenic shock;
  • Refuse to sign the written informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Changzhou Wujin People's Hospital

    Changzhou, Jiangsu, 213017

Other trials in China

About this study

Official title: Prevalence of Distal Radial Artery Occlusion (DRAO) in Patients Undergoing Cardiovascular Catheterization Via Distal Radial Access (DRA)

Explore the prevalence of distal radial artery occlusion after cardiac catheterization via distal radial artery and the risk factors

Read the detailed description

Cardiac catheterization via distal radial artery is prevalent worldwide, which can reduce the prevalence of radial artery occlusion. However, the distal radial artery occlusion has not been detected. This study is designed to explore the prevalence of distal radial artery occlusion in patients undergoing cardiac catheterization via distal radial access at 1 day and 3 months after the procedure, which is explored by ultrasound. In addition, the risk factors of distal radial artery occlusion are also analyzed.

Being tested
cardiac catheterization via distal radial artery
Keywords
distal radial artery occlusion;cardiac catheterization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cardiac catheterization via distal radial arteryProcedure or surgery

    cardiac catheterization via distal radial artery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of distal radial artery occlusion

    Prevalence of the distal radial artery occlusion is detected using ultrasound

    Measured: 3 months after procedure

Secondary outcomes (2)

  1. Prevalence of distal radial artery occlusion

    Prevalence of the distal radial artery occlusion is detected using ultrasound

    Measured: 1 day after procedure

  2. Thickness of distal radial artery

    Comparison of the thickness of distal radial artery intima using ultrasound

    Measured: 3 months after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2022
  2. Study start1 Mar 2022
  3. Primary completion18 Dec 2023
  4. Study completion18 Dec 2023

Resources

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
Cohort
Time perspective
Prospective
Enrolment
805 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05317533
Sponsor's protocol ID
CLH20220312
Status last verified
Dec 2023
First submitted
30 Mar 2022
Last updated
19 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lin Y, Sun X, Chen R, Liu H, Pang X, Chen J, Dong S. Feasibility and Safety of the Distal Transradial Artery for Coronary Diagnostic or Interventional Catheterization. J Interv Cardiol. 2020 Dec 9;2020:4794838. doi: 10.1155/2020/4794838. eCollection 2020.

    PubMed 33380922

  • Sgueglia GA, Di Giorgio A, Gaspardone A, Babunashvili A. Anatomic Basis and Physiological Rationale of Distal Radial Artery Access for Percutaneous Coronary and Endovascular Procedures. JACC Cardiovasc Interv. 2018 Oct 22;11(20):2113-2119. doi: 10.1016/j.jcin.2018.04.045.

    PubMed 30336816

  • Sattar Y, Talib U, Faisaluddin M, Song D, Lak HM, Laghari A, Khan MZ, Ullah W, Elgendy IY, Balla S, Daggubati R, Kawsara A, Jneid H, Alraies CM, Alam M. Meta-Analysis Comparing Distal Radial Versus Traditional Radial Percutaneous Coronary Intervention or Angiography. Am J Cardiol. 2022 May 1;170:31-39. doi: 10.1016/j.amjcard.2022.01.019. Epub 2022 Mar 2.

    PubMed 35248389

  • Prasad RM, Pandrangi P, Pandrangi G, Yoo H, Salazar AM, Ukponmwan E, Kehdi M, Abela G. Meta-Analysis Comparing Distal Radial Artery Approach Versus Traditional for Coronary Procedures. Am J Cardiol. 2022 Feb 1;164:52-56. doi: 10.1016/j.amjcard.2021.10.034. Epub 2021 Nov 20.

    PubMed 34815063

  • Pacchioni A, Mugnolo A, Sanz Sanchez J, Sgueglia GA, Pesarini G, Bellamoli M, Sacca S, Ribichini F, Reimers B, Gasparini GL. Radial artery occlusion after conventional and distal radial access: Impact of preserved flow and time-to-hemostasis in a propensity-score matching analysis of 1163 patients. Catheter Cardiovasc Interv. 2022 Feb;99(3):827-835. doi: 10.1002/ccd.30005. Epub 2021 Nov 16.

    PubMed 34783423

  • Aminian A, Sgueglia GA, Wiemer M, Gasparini GL, Kefer J, Ruzsa Z, van Leeuwen MAH, Vandeloo B, Ungureanu C, Kedev S, Iglesias JF, Leibundgut G, Ratib K, Bernat I, Barriocanal I, Borovicanin V, Saito S. Distal versus conventional radial access for coronary angiography and intervention: Design and rationale of DISCO RADIAL study. Am Heart J. 2022 Feb;244:19-30. doi: 10.1016/j.ahj.2021.10.180. Epub 2021 Oct 16.

    PubMed 34666014

  • Li F, Shi GW, Yu XL, Song RX, Xiao JQ, Huang HM, Li LM, Zhang LY, Gong C, Cai GJ. Safety and efficacy of coronary angiography and percutaneous coronary intervention via distal transradial artery access in the anatomical snuffbox: a single-centre prospective cohort study using a propensity score method. BMC Cardiovasc Disord. 2022 Mar 2;22(1):74. doi: 10.1186/s12872-022-02518-8.

    PubMed 35236288

  • Shi G, Li F, Zhang L, Gong C, Xue S, Song Y, Cai G. Retrograde Recanalization of Occluded Radial Artery: A Single-Centre Experience and Literature Review. J Endovasc Ther. 2022 Oct;29(5):755-762. doi: 10.1177/15266028211067732. Epub 2022 Jan 10.

    PubMed 35001676

Questions about this trial

What is this clinical trial studying?

An observational study of Catheterization and Complications, run by Wujin 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 2 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: finished, as of the sponsor's last update on 19 Dec 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of distal radial artery occlusion (time frame: 3 months after procedure). 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 NCT05317533, which also lists 8 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 19 Dec 2023.

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