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Coronary Artery DiseaseCONDITIONNCT05253820

Long-term Radial Artery Occlusion in Coronary Diagnosis and Intervention Via Distal Radial Approach (CONDITION)

A study testing distal radial approach and conventional radial access in people with Coronary Artery Disease and Distal Radial Artery, 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

Randomized-controlled trial to comparison of the long-term radial artery occlusion in coronary diagnosis and intervention via distal vs conventional radial approach Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
distal radial approach and conventional radial access
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
801 participants
Where
1 siteChina
Study dates
1 Mar 2022to 1 Aug 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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years;
  • Palpable unilateral distal radial and radial artery

Who cannot join

  • Age ≥ 90years;
  • Height≥ 185cm;
  • Cardiogenic shock;
  • Contraindications to puncture at the puncture site;
  • Inability to obtain written informed consent
  • Previous right radial or distal artery intervention

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: Comparison of the Long-term Radial Artery Occlusion in Coronary Diagnosis and Intervention Via Distal vs Conventional Radial Approach: Randomized-controlled Trial(CONDITION)

Randomized-controlled trial to comparison of the long-term radial artery occlusion in coronary diagnosis and intervention via distal vs conventional radial approach

Read the detailed description

Coronary diagnosis and intervention via distal radial artery is prevalent worldwide. This study aims to explore the long-term radial artery occlusion after coronary diagnosis and intervention via distal radial artery at 3 months after procedure using portable high-frequent ultrasound. The secondary endpoints include the success rate of puncture, time of puncture, duration of hemostasis, radial artery trauma, etc.

Being tested
distal radial approach, conventional radial access
Keywords
coronary artery disease, distal radial artery, conventional radial artery, radial artery occlusion
Medical subject headings
Coronary Artery Disease, Arterial Occlusive Diseases

What participants receive

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

  • distal radial approachProcedure or surgery

    coronary diagnosis and intervention via distal vs conventional radial approach

  • conventional radial accessProcedure or surgery

    conventional radial access

Study groups in NCT05253820
Study groupRoleWhat they receive
distal radial approach groupExperimentalsubjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial approach
Receives: Procedure: distal radial approach
conventional radial access groupActive comparatorsubjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial approach
Receives: Procedure: conventional radial access

What is being measured

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

  1. long-term radial artery occlusion

    Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 3 months after procedure

    Measured: 3 months after procedure

Secondary outcomes (4)

  1. radial artery occlusion

    Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 24 hours after procedure

    Measured: at 24 hours after procedure

  2. success rate of puncture

    Success of puncture is defined as the sheath inserted into the artery

    Measured: at 24 hours post procedure

  3. time of puncture

    time of puncture is defined as the time from initial puncture to the sheath inserted into the artery

    Measured: at 24 hours post procedure

  4. Radial artery trauma

    Number of participants with radial artery trauma in the radial and distal radial artery, such as the intimal tears, dissections, thrombosis, and pseudoaneurysms in the radial and distal radial artery, which is detected by ultrasound

    Measured: at 24 hours and 3 months post procedure

Timeline

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

  1. First posted24 Feb 2022
  2. Study start1 Mar 2022
  3. Primary completion31 Mar 2023
  4. Study completion1 Aug 2023

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Single-center parallel randomized controlled study
Masking
None (open label)
Enrolment
801 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05253820
Sponsor's protocol ID
20220130
Acronym
CONDITION
Status last verified
Oct 2023
First submitted
3 Feb 2022
Last updated
10 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gupta A, Agstam S. Radial Artery Pseudoaneurysm Following Percutaneous Coronary Intervention. J Invasive Cardiol. 2021 May;33(5):E406. doi: 10.25270/jic/20.00272.

    PubMed 33932290

  • Rashid M, Kwok CS, Pancholy S, Chugh S, Kedev SA, Bernat I, Ratib K, Large A, Fraser D, Nolan J, Mamas MA. Radial Artery Occlusion After Transradial Interventions: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2016 Jan 25;5(1):e002686. doi: 10.1161/JAHA.115.002686.

    PubMed 26811162

  • Tehrani DM, Seto AH. Heparin, compression, and radial artery occlusion: Less is more. Catheter Cardiovasc Interv. 2021 Jun 1;97(7):1377-1378. doi: 10.1002/ccd.29764. No abstract available.

    PubMed 34107564

  • Hadjivassiliou A, Kiemeneij F, Nathan S, Klass D. Ultrasound-guided access to the distal radial artery at the anatomical snuffbox for catheter-based vascular interventions: a technical guide. EuroIntervention. 2021 Mar 19;16(16):1342-1348. doi: 10.4244/EIJ-D-19-00555.

    PubMed 31380781

  • Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 20;13(7):851-857. doi: 10.4244/EIJ-D-17-00079.

    PubMed 28506941

  • Soydan E, Akin M. Applicability of left distal radial artery access site in ST-segment elevation myocardial infarction; A comparative evaluation with the conventional transfemoral approach. J Vasc Access. 2022 Jan;23(1):81-87. doi: 10.1177/1129729820983138. Epub 2020 Dec 21.

    PubMed 33349158

  • Colletti G, Auslender J, De Meester A, Aminian A, Kayaert P, Ungureanu C. Feasibility and Safety of Performing Complex Coronary Interventions by Distal Radial Artery Using the Railway Sheathless Vascular System. J Invasive Cardiol. 2020 Dec;32(12):459-462. doi: 10.25270/jic/20.00201. Epub 2020 Oct 10.

    PubMed 33035178

  • 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

  • Tsigkas G, Papageorgiou A, Moulias A, Kalogeropoulos AP, Papageorgopoulou C, Apostolos A, Papanikolaou A, Vasilagkos G, Davlouros P. Distal or Traditional Transradial Access Site for Coronary Procedures: A Single-Center, Randomized Study. JACC Cardiovasc Interv. 2022 Jan 10;15(1):22-32. doi: 10.1016/j.jcin.2021.09.037. Epub 2021 Dec 15.

    PubMed 34922888

  • Mhanna M, Beran A, Nazir S, Al-Abdouh A, Barbarawi M, Sajdeya O, Ayesh H, Nesheiwat Z, Malhas SE, Eltahawy EA. Outcomes of distal versus conventional transradial access for coronary angiography and intervention: An updated systematic review and meta-analysis. Int J Cardiol. 2021 Dec 1;344:47-53. doi: 10.1016/j.ijcard.2021.10.003. Epub 2021 Oct 6.

    PubMed 34626744

  • Eid-Lidt G, Rivera Rodriguez A, Jimenez Castellanos J, Farjat Pasos JI, Estrada Lopez KE, Gaspar J. Distal Radial Artery Approach to Prevent Radial Artery Occlusion Trial. JACC Cardiovasc Interv. 2021 Feb 22;14(4):378-385. doi: 10.1016/j.jcin.2020.10.013.

    PubMed 33602433

  • Hamilton GW, Farouque O. Could Distal Radial Artery Access do More Than "Just" Reduce Rates of Radial Artery Occlusion? JACC Cardiovasc Interv. 2021 May 10;14(9):1042-1043. doi: 10.1016/j.jcin.2021.03.055. No abstract available.

    PubMed 33958163

  • Li F, Zhou T, Fan X, Chen T, Shi G, Li L, Cai G. Safety and Efficacy of Distal Transradial Access in Patients With Small Diameter Distal Radial Artery: A Post Hoc Analysis of 2 Randomized Trials. Can J Cardiol. 2026 Jun;42(6):1221-1229. doi: 10.1016/j.cjca.2025.12.048. Epub 2025 Dec 30.

    PubMed 41478549

  • Chen T, Li L, Li F, Lu W, Shi G, Li W, Yang A, Huang H, Xiao J, Zhang Q, Gu J, Xue S, Zhang L, Li L, Xu L, Ji R, Wang H, Cai G. Comparison of long-term radial artery occlusion via distal vs. conventional transradial access (CONDITION): a randomized controlled trial. BMC Med. 2024 Feb 8;22(1):62. doi: 10.1186/s12916-024-03281-7.

    PubMed 38331793

Questions about this trial

What is this clinical trial studying?

A study testing distal radial approach and conventional radial access in people with Coronary Artery Disease and Distal Radial Artery, 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 6 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 10 Oct 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?

long-term 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 NCT05253820, which also lists 14 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 10 Oct 2023.

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