DIStal Versus COnventional RADIAL Access for Coronary Angiography and Intervention
DISCO Radial Trial: DIStal Versus COnventional RADIAL Access for Coronary Angiography and Intervention: a Randomized Multicenter Trial
1 other identifier
interventional
1,309
10 countries
16
Brief Summary
The objective of this study is to demonstrate the superiority of Distal Radial Access (DTRA) to Conventional Transradial Access (CTRA) regarding forearm radial artery occlusion (RAO). This trial plans to include 1300 patients in around 12 locations around the world (11 participating sites in Europe and 1 participating site in Japan).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2019
Typical duration for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2019
CompletedFirst Posted
Study publicly available on registry
November 21, 2019
CompletedStudy Start
First participant enrolled
December 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2021
CompletedMay 24, 2022
May 1, 2022
2.1 years
October 23, 2019
May 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Forearm radial artery occlusion (RAO) rate before discharge
Forearm radial artery occlusion (RAO) rate before discharge measured with Doopler Ultrasound
up to 5 days
Secondary Outcomes (12)
Rate of successful sheath insertion
up to 2 days
Rate of access site crossover
up to 2 days
Total procedural time
up to 2 days
Sheath insertion time
up to 2 days
Puncture site bleeding according to EASY criteria
up to 5 days
- +7 more secondary outcomes
Study Arms (2)
Distal Transradial Access
OTHERDistal Transradial Access
Conventional Transradial Access
OTHERConventional Transradial Access
Interventions
Radial access punture site
Eligibility Criteria
You may qualify if:
- Patient is at least 18 years of age.
- Patient has provided written informed consent.
- Patient is undergoing diagnostic coronary angiography and/or PCI.
- Patient is willing to comply with all protocol-required evaluations during the hospitalization.
- Patient is suitable for both DTRA and CTRA using 6Fr GSS.
You may not qualify if:
- Patient has a medical condition that may cause non-compliance with the protocol and/or confound the data interpretation.
- Patients on chronic hemodialysis.
- Patients presenting with ST-elevated myocardial infarction (STEMI).
- Patients have chronic total occlusion (CTO) lesions in coronary artery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Terumo Europe N.V.lead
- Cromsourcecollaborator
Study Sites (16)
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium
Hôpital Civil Marie Curie
Charleroi, Hainaut, 6042, Belgium
CHU Jolimont
Haine-Saint-Paul, Hainaut, 7100, Belgium
UZ Brussel
Brussels, 1090, Belgium
Plzen Medical University
Pilsen, 306 05, Czechia
University Hospital Johannes Wesling Klinikum Minden
Minden, 32429, Germany
Bács-Kiskun Megyei Kórház
Kecskemét, 6000, Hungary
Sant'Eugenio Hospital
Roma, 00144, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Shonan Kamakura General Hospital
Kanagawa, 247-8533, Japan
Isala Hospital
Zwolle, 8025 AB, Netherlands
University Clinic of Cardiology, Skopje
Skopje, 1000, North Macedonia
HUG Geneva
Geneva, 1211, Switzerland
Kantonsspital Baselland Liestal
Liestal, CH-4410, Switzerland
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG, United Kingdom
Sunderland Royal Hospital
Sunderland, United Kingdom
Related Publications (4)
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: 28506941BACKGROUNDCorcos T. Distal radial access for coronary angiography and percutaneous coronary intervention: A state-of-the-art review. Catheter Cardiovasc Interv. 2019 Mar 1;93(4):639-644. doi: 10.1002/ccd.28016. Epub 2018 Dec 11.
PMID: 30536709BACKGROUNDSgueglia 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.
PMID: 30336816BACKGROUNDAminian A, Saito S, Takahashi A, Bernat I, Jobe RL, Kajiya T, Gilchrist IC, Louvard Y, Kiemeneij F, Van Royen N, Yamazaki S, Matsukage T, Rao SV. Comparison of a new slender 6 Fr sheath with a standard 5 Fr sheath for transradial coronary angiography and intervention: RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT), a randomised multicentre trial. EuroIntervention. 2017 Aug 4;13(5):e549-e556. doi: 10.4244/EIJ-D-16-00816.
PMID: 28218605BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adel Aminian, Dr.
Hôpital Civil Marie Curie
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2019
First Posted
November 21, 2019
Study Start
December 10, 2019
Primary Completion
December 28, 2021
Study Completion
December 28, 2021
Last Updated
May 24, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share