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

Percutaneous Coronary Intervention Clinical Trial

— REPEAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05340998
• Other study ID #: Pertini06
• Status: Recruiting
• Start date: July 15, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: Ospedale Sandro Pertini, Roma
• Contact: Alessandro Sciahbasi, MD, Phd
• Phone: +390641433870
• Email: asciahbasi[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1350
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Angiography
• Percutaneous Coronary Intervention

Intervention

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

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Sandro Pertini, Roma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Minor bleeding	The rate of minor bleeding in crossover vs non crossover groups	up to seven days