Clinical trial NCT05340998: Radial accEss Crossover for PErcutaneous Coronary Procedures And ouTcome: the REPEAT Study
Official title: Radial accEss Crossover for PErcutaneous Coronary Procedures And ouTcome: the REPEAT Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Angiography
Percutaneous Coronary Intervention
Lead sponsor: Ospedale Sandro Pertini, Roma
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 1357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an indication to percutaneous coronary procedures performed through transradial approach

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)

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

Primary outcomes:
measure: Vascular complications and major bleeding
timeFrame: up to seven days
Secondary outcomes:
measure: Minor bleeding
timeFrame: up to seven days
Other outcomes:
Locations:
city: Avezzano
country: Italy
facility: Ospedale di Avezzano
city: Roma
country: Italy
facility: Ospedale S. Andrea
city: Roma
country: Italy
facility: Ospedale S. Camillo
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
city: Roma
country: Italy
facility: Ospedale Santo Spirito
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Sassari
country: Italy
facility: Ospedale di Sassari
city: Teramo
country: Italy
facility: Ospedale di Teramo
city: Trento
country: Italy
facility: Ospedale di Trento
Study officials:
References: