Ignite Creation Date:
2024-05-06 @ 4:05 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02454491
Status:
COMPLETED
Last Update Posted:
2016-10-04
First Post:
2015-05-13
Brief Title:
Verapamil vs Heparin in Transradial Procedures
Sponsor:
University Hospital of Ferrara
Organization:
University Hospital of Ferrara
Study Overview
Official Title:
Comparison of VERapamil vs Heparin Therapy on Procedural sUccess During Transradial Coronary Procedures VERMUT Study
Status:
COMPLETED
Status Verified Date:
2016-10
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:
VERMUT
Brief Summary:
Transradial approach TRA for cardiac catheterization and percutaneous coronary interventions PCI is increasingly being used worldwide At the present is unknown the cocktail of agents necessary to minimize local access site complications The investigators planned a prospective randomized clinical trial to test the superiority of verapamil vs heparin in the reduction of access site related complications
Detailed Description:
Transradial approach TRA for cardiac catheterization and percutaneous coronary interventions PCI is increasingly being used worldwide in both elective and emergency procedures because it reduces net adverse clinical events through a reduction in major bleeding and all-cause mortality when compared to transfemoral approach However radial artery occlusion RAO after the procedure the incidence of which varies from 1 to 10 remains one of the major limitations of TRA
The aim of the study is to assess the superiority of verapamil versus heparin in the access success during transradial percutaneous coronary interventions PCI
METHODS Patients referred to the cath-lab of the Cardiovascular Institute of the University Hospital of Ferrara Italy for coronary angiography were randomized in 2 groups with a computer-generated random sequence The study is double-blind In the first group patients received intravenous heparin 5000 UI immediately after a 6 F sheath insertion In the second group patients received Verapamil 5 mg immediately after a 6 F sheath insertion If after the start of the procedure a radial artery spasm RAS occurs the operators can choose to use bail-out a local vasodilator therapy After sheath removal hemostasis was obtained using a TR band Terumo corporation Tokyo Japan with a plethysmography-guided patent hemostasis technique Radial artery patency was evaluated at 24 hours early RAO and 30 days after the procedure late RAO by ultrasound
The aim of the study is to demonstrate that verapamil administration is superior to heparin administration in the reduction of the combined endpoint occurrence of radial artery occlusion early RAO access site complication radial artery spasm RAS requiring local bailout use of vasodilatator
RAO will be assessed by ultrasonography by independent expert reviewer blinded to randomization
The investigators defined access site complication the following items
local haematoma superficial 5 cm from access site
haematoma with moderate muscle infiltration 10 cm
forearm haematoma and muscular infiltration below the elbow
haematoma and muscular infiltration above the elbow
ischemic threat compartmental syndrome
radial artery dissection during the procedure
The investigators defined radial artery spasm any spasm occurring during the procedure requiring the administration of local vasodilatators to allow the procedure
The aim of the study is to assess the superiority of verapamil versus heparin in the access success during transradial percutaneous coronary interventions PCI
METHODS Patients referred to the cath-lab of the Cardiovascular Institute of the University Hospital of Ferrara Italy for coronary angiography were randomized in 2 groups with a computer-generated random sequence The study is double-blind In the first group patients received intravenous heparin 5000 UI immediately after a 6 F sheath insertion In the second group patients received Verapamil 5 mg immediately after a 6 F sheath insertion If after the start of the procedure a radial artery spasm RAS occurs the operators can choose to use bail-out a local vasodilator therapy After sheath removal hemostasis was obtained using a TR band Terumo corporation Tokyo Japan with a plethysmography-guided patent hemostasis technique Radial artery patency was evaluated at 24 hours early RAO and 30 days after the procedure late RAO by ultrasound
The aim of the study is to demonstrate that verapamil administration is superior to heparin administration in the reduction of the combined endpoint occurrence of radial artery occlusion early RAO access site complication radial artery spasm RAS requiring local bailout use of vasodilatator
RAO will be assessed by ultrasonography by independent expert reviewer blinded to randomization
The investigators defined access site complication the following items
local haematoma superficial 5 cm from access site
haematoma with moderate muscle infiltration 10 cm
forearm haematoma and muscular infiltration below the elbow
haematoma and muscular infiltration above the elbow
ischemic threat compartmental syndrome
radial artery dissection during the procedure
The investigators defined radial artery spasm any spasm occurring during the procedure requiring the administration of local vasodilatators to allow the procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None