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

Completed

• Conditions: Percutaneous Coronary Intervention; Coronary Angiography
• Interventions: Procedure: Transradial access for percutaneous coronary procedures

• Registration Number: NCT05340998
• Lead Sponsor: Ospedale Sandro Pertini, Roma

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)

Study Timeline

• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-22
• Study Start: 2022-07-15
• Primary Completion: 2025-01-15
• Study Completion: 2025-01-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1357

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non Crossover Group	Transradial access for percutaneous coronary procedures	Patients with successful transradial access for percutaneous coronary procedures
Crossover Group	Transradial access for percutaneous coronary procedures	Patients with Transradial access failure for percutaneous coronary procedures necessitating vascular crossover

Primary Outcome Measures

Name	Time	Method
Vascular complications and major bleeding	up to seven days	The rate of in-hospital vascular complications and major bleeding in crossover vs non crossover groups

Secondary Outcome Measures

Name	Time	Method
Minor bleeding	up to seven days	The rate of minor bleeding in crossover vs non crossover groups

Trial Locations

Locations (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