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

NCT05253820 | Completed

• 1 other identifier: 20220130
• Study Type: interventional
• Target: 801
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease; Distal Radial Artery; Radial Artery Occlusion

Keywords

coronary artery disease; distal radial artery; conventional radial artery; radial artery occlusion

Outcome Measures

Primary Outcomes (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

  3 months after procedure

Secondary Outcomes (4)

• radial artery occlusion

  at 24 hours after procedure

• success rate of puncture

  at 24 hours post procedure

• time of puncture

  at 24 hours post procedure

• Radial artery trauma

  at 24 hours and 3 months post procedure

Study Arms (2)

distal radial approach group

EXPERIMENTAL

subjects randomized to experimental group were underwent coronary diagnosis and intervention via distal radial approach

Procedure: distal radial approach

conventional radial access group

ACTIVE COMPARATOR

subjects randomized to active comparator group were underwent coronary diagnosis and intervention via conventional radial approach

Procedure: conventional radial access

Interventions

distal radial approach PROCEDURE

coronary diagnosis and intervention via distal vs conventional radial approach

distal radial approach group

conventional radial access PROCEDURE

conventional radial access

conventional radial access group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wujin People's Hospital: lead

Study Sites (1)

Changzhou Wujin People's Hospital

Changzhou, Jiangsu, 213017, China

Location

Related Publications (14)

• 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.

  PMID: 33932290 RESULT

• 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.

  PMID: 26811162 RESULT

• 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.

  PMID: 34107564 RESULT

• 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.

  PMID: 31380781 RESULT

• 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.

  PMID: 28506941 RESULT

• 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.

  PMID: 33349158 RESULT

• 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.

  PMID: 33035178 RESULT

• 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.

  PMID: 33380922 RESULT

• 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.

  PMID: 34922888 RESULT

• 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.

  PMID: 34626744 RESULT

• 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.

  PMID: 33602433 RESULT

• 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.

  PMID: 33958163 RESULT

• 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. 2025 Dec 30:S0828-282X(25)01616-2. doi: 10.1016/j.cjca.2025.12.048. Online ahead of print.

  PMID: 41478549 DERIVED

• 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.

  PMID: 38331793 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Vascular Diseases

Study Officials

• Gaojun Cai, MD

  Cardiovascular department, Changzhou Wujin People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center parallel randomized controlled study

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 24, 2022
• Study Start: March 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: August 1, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)