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Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention

Randomized Comparison of Distal Radial Versus Conventional Radial Access for Coronary Angiography and Intervention

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04784078
Enrollment
938
Registered
2021-03-05
Start date
2021-04-10
Completion date
2022-01-31
Last updated
2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease

Keywords

Distal radial artery, Radial access

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.

Interventions

PROCEDURECoronary Angiography and Intervention

Transradial access puncture site

Sponsors

Beijing Anzhen Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Radial artery occlusionWithin 24 hours after the procedure.Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups. Incidence of radial artery occlusion as confirmed by absense of antegrade flow in vascular doppler ultrasound.

Contacts

Primary ContactLixia Yang, Doctor
ylx966@163.com13661339066

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026