Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05340998
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2022-04-14
Brief Title:
Radial accEss Crossover for PErcutaneous Coronary Procedures And ouTcome the REPEAT Study
Sponsor:
Ospedale Sandro Pertini Roma
Organization:
Ospedale Sandro Pertini Roma
Study Overview
Official Title:
Radial accEss Crossover for PErcutaneous Coronary Procedures And ouTcome the REPEAT Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPEAT
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 21 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 gdL 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
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 gdL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None