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

Coronary Artery Disease Clinical Trial

— CONDITION  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05253820
• Other study ID #: 20220130
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: October 2023
• Source: Wujin People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: August 1, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age = 18 years;

• Palpable unilateral distal radial and radial artery

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Radial Artery Occlusion

Intervention

Procedure:
• distal radial approach
coronary diagnosis and intervention via distal vs conventional radial approach
• conventional radial access
conventional radial access

Locations

Country	Name	City	State
China	Changzhou Wujin People's Hospital	Changzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Wujin People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

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 — View Citation

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. — View Citation

Gupta A, Agstam S. Radial Artery Pseudoaneurysm Following Percutaneous Coronary Intervention. J Invasive Cardiol. 2021 May;33(5):E406. — View Citation

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/EI — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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-analy — View Citation

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. — View Citation

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: 10.1177/112972982098313 — View Citation

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. — View Citation

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 — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	radial artery occlusion	Number of participants with the forearm radial artery occlusion is detected using high-frequent ultrasound at 24 hours after procedure	at 24 hours after procedure
Secondary	success rate of puncture	Success of puncture is defined as the sheath inserted into the artery	at 24 hours post procedure
Secondary	time of puncture	time of puncture is defined as the time from initial puncture to the sheath inserted into the artery	at 24 hours post procedure
Secondary	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	at 24 hours and 3 months post procedure