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

NCT ID: NCT05340998

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1357 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2025-01-16

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

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)

Conditions

Coronary Angiography; Percutaneous Coronary Intervention

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Crossover Group

Patients with Transradial access failure for percutaneous coronary procedures necessitating vascular crossover

Transradial access for percutaneous coronary procedures

Intervention Type: PROCEDURE

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

Transradial access for percutaneous coronary procedures

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Sandro Pertini, Roma

OTHER

Sponsor Role: lead

Responsible Party

Alessandro Sciahbasi, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Countries

Italy

Other Identifiers

Pertini06

Identifier Type: -

Identifier Source: org_study_id