Clinical trial NCT04784078: Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention
Official title: Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Disease
Keywords: Distal radial artery
Radial access
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 938
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Distal radial access (dTRA) represents a novel site for radial artery access in interventional cardiology, there is little data compare dTRA with conventional radial access (cTRA) in a randomized manner.

It aims to randomly compare between the new distal radial access via the snuffbox and the conventional radial access for percutaneous coronary intervention (PCI) and angioplasty procedures. The objectives of comparing both procedures are to analyze the frequency of complications in terms of occlusion, arterial spasm, hematoma, and to weigh accesses effectiveness in terms of time and attempts to puncture, crossover rate, procedure duration, hemostasis time.

Candidates for coronary angiography are being randomized into the interventional group to undergo the angiography through the distal radial artery as the access site, or the control group accessing through the radial artery. Procedural and post procedural outcomes and complications are being reported while patients are in hospital. All patients undergo doppler ultrasonography within 24 hours before and after the procedure, 4 weeks after procedure.


Eligibility criteria: Inclusion Criteria:

* Patient is over 18 years of age.
* Patient is undergoing diagnostic coronary angiography and/or PCI for the first time.
* Patient has provided written informed consent.
* Patient is willing to comply with all protocol-required evaluations during the hospitalization.

Exclusion Criteria:

* No palpable radial artery or distal radial artery.
* Radial artery used as a bridging vessel.
* Severe heart failure (NYHA class IV).
* Severe renal insufficiency ( SCr\>443umol/L).
* Height over 185 cm.
* A ≥7F catheter may be required for operation.

Primary outcomes:
measure: Radial artery occlusion
timeFrame: Within 24 hours after the procedure.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Anzhen Hospital
name: Yujie Zhou, Doctor
role: STUDY_CHAIR
References:
citation: Nikolakopoulos I, Vemmou E, Brilakis ES. Distal radial access for cardiac catheterization: When and how. Hellenic J Cardiol. 2020 Mar-Apr;61(2):110-111. doi: 10.1016/j.hjc.2020.06.001. Epub 2020 Jun 14. No abstract available.
citation: Liontou C, Kontopodis E, Oikonomidis N, Maniotis C, Tassopoulos A, Tsiafoutis I, Lazaris E, Koutouzis M. Distal Radial Access: A Review Article. Cardiovasc Revasc Med. 2020 Mar;21(3):412-416. doi: 10.1016/j.carrev.2019.06.003. Epub 2019 Jun 8.
citation: 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.
citation: Koutouzis M, Kontopodis E, Tassopoulos A, Tsiafoutis I, Katsanou K, Rigatou A, Didagelos M, Andreou K, Lazaris E, Oikonomidis N, Maniotis C, Ziakas A. Distal Versus Traditional Radial Approach for Coronary Angiography. Cardiovasc Revasc Med. 2019 Aug;20(8):678-680. doi: 10.1016/j.carrev.2018.09.018. Epub 2018 Oct 2.
citation: Xenogiannis I, Brilakis ES. Distal radial access at the anatomic snuffbox: The new standard for left radial access? Catheter Cardiovasc Interv. 2019 Nov 1;94(5):658-659. doi: 10.1002/ccd.28551. No abstract available.