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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Coronary Angiography, Percutaneous Coronary Intervention

Intervention / Treatment
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* Procedure: Transradial access for percutaneous coronary procedures


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Crossover Group<br>Patients with Transradial access failure for percutaneous coronary procedures necessitating vascular crossover | Procedure: Transradial access for percutaneous coronary procedures<br>* 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<br>|
| Non Crossover Group<br>Patients with successful transradial access for percutaneous coronary procedures | Procedure: Transradial access for percutaneous coronary procedures<br>* 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<br>|

What is the study measuring?
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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 |