Radial accEss Crossover for PErcutaneous Coronary Procedures And ouTcome: the REPEAT Study (REPEAT)

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

Study Overview

• Status: Completed
• Conditions: Percutaneous Coronary Intervention; Coronary Angiography
• Intervention / Treatment: Procedure: Transradial access for percutaneous coronary procedures

Detailed Description

All patients who undergo to percutaneous coronary diagnostic or interventional procedures through transradial approach (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 enrolled (2:1 rate compared to crossover group to avoid possible selection bias) after signing a dedicated written informed consent.

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.

According to the selected secondary access, patients will be divided in two groups: patients with a secondary (or tertiary) wrist access (total wrist Group) and patients with a crossover to femoral (Femoral Group). Patients included in the total wrist group may have a secondary access to the ulnar artery (ipsilateral or contralateral) or to the contralateral radial.

All patients will be checked during the procedure, immediately after and 24 hour post to evaluate possible vascular complications and bleeding.

Patient baseline characteristics, hospital data, comorbid conditions and complications will be recorded in a dedicated electronic case report form.

Exclusion criteria will be: lack of signed informed consent, age <18 years.

Primary End point of the study is the rate of in-hospital vascular complications and major bleeding in crossover vs non crossover groups.

Secondary End-points are:

• The rate of vascular complications or bleeding in total wrist vs femoral Group.
• The rate of minor bleeding
• Procedure duration
• Fluoroscopy time
• Number of catheters employed
• Differences among operators and Centers

Vascular complications are defined as any vascular damage clinically documented as vessel perforation, arterial-venous fistula, pseudoaneurysm, arterial dissection, retroperitoneal hematoma and compartmental syndrome. Major bleeding complications are defined according to the BARC classification, as BARC 3 (overt bleeding plus a hemoglobin drop > 3 g/dL; any transfusion with overt bleeding, cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring intravenous vasoactive agents and intracranial haemorrhage) and BARC 5 (fatal bleeding).

Minor bleeding is defined as Hematoma larger than 10 cm not requiring medical intervention (Easy III)

• Study Type: Observational
• Enrollment (Actual): 1357

Contacts and Locations

Study Locations

• Italy
  • Avezzano, Italy
    • Ospedale di Avezzano
  • Roma, Italy
    • Ospedale Sandro Pertini
  • Roma, Italy
    • Policlinico Agostino Gemelli
  • Roma, Italy
    • Policlinico Umberto I
  • Roma, Italy
    • Ospedale S. Camillo
  • Roma, Italy
    • Ospedale Santo Spirito
  • Roma, Italy
    • Ospedale S. Andrea
  • Sassari, Italy
    • Ospedale di Sassari
  • Teramo, Italy
    • Ospedale di Teramo
  • Trento, Italy
    • Ospedale di Trento

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with an indication to percutaneous coronary procedures performed through transradial approach

Description

Inclusion Criteria:

• All patients who undergo to percutaneous coronary diagnostic or interventional procedures through transradial access

Exclusion Criteria:

• Lack of signed informed consent, age <18 years

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Crossover Group; Patients with Transradial access failure for percutaneous coronary procedures necessitating vascular crossover	Procedure: Transradial access for percutaneous coronary procedures; 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
Non Crossover Group; Patients with successful transradial access for percutaneous coronary procedures	Procedure: Transradial access for percutaneous coronary procedures; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minor bleeding	The rate of minor bleeding in crossover vs non crossover groups	up to seven days

Collaborators and Investigators

• Sponsor: Ospedale Sandro Pertini, Roma

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 16, 2025

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Pertini06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No