Radial accEss Crossover for PErcutaneous Coronary Procedures And ouTcome: the REPEAT Study
REPEAT
1 other identifier
observational
1,357
1 country
10
Brief Summary
All patients who undergo to percutaneous coronary diagnostic or interventional procedures through transradial access (TRA) will be screened for inclusion in this prospective observational study and patients with TRA failure necessitating vascular crossover will be included in the Registry after signing a dedicated written informed consent. A Control group of consecutive patients with radial access and without crossover will be included. Primary end point of the study is the rate of in-hospital vascular complications and major bleeding in crossover vs non crossover groups
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2022
CompletedFirst Posted
Study publicly available on registry
April 22, 2022
CompletedStudy Start
First participant enrolled
July 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2025
CompletedMarch 13, 2025
March 1, 2025
2.5 years
April 14, 2022
March 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Vascular complications and major bleeding
The rate of in-hospital vascular complications and major bleeding in crossover vs non crossover groups
up to seven days
Secondary Outcomes (1)
Minor bleeding
up to seven days
Study Arms (2)
Crossover Group
Patients with Transradial access failure for percutaneous coronary procedures necessitating vascular crossover
Non Crossover Group
Patients with successful transradial access for percutaneous coronary procedures
Interventions
Transradial approach for percutaneous coronary procedures. The modality of radial puncture (needle vs cannula), the choice of radial sheath (long vs short; hydrophilic vs non hydrophilic), the type of catheters employed, the use of spasmolytic agents and the choice of secondary vascular access will be left to the operator discretion
Eligibility Criteria
Patients with an indication to percutaneous coronary procedures performed through transradial approach
You may qualify if:
- All patients who undergo to percutaneous coronary diagnostic or interventional procedures through transradial access
You may not qualify if:
- Lack of signed informed consent, age \<18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Ospedale di Avezzano
Avezzano, Italy
Ospedale S. Andrea
Roma, Italy
Ospedale S. Camillo
Roma, Italy
Ospedale Sandro Pertini
Roma, Italy
Ospedale Santo Spirito
Roma, Italy
Policlinico Agostino Gemelli
Roma, Italy
Policlinico Umberto I
Roma, Italy
Ospedale di Sassari
Sassari, Italy
Ospedale di Teramo
Teramo, Italy
Ospedale di Trento
Trento, Italy
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 14, 2022
First Posted
April 22, 2022
Study Start
July 15, 2022
Primary Completion
January 15, 2025
Study Completion
January 16, 2025
Last Updated
March 13, 2025
Record last verified: 2025-03