Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289946
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-26
Brief Title:
Topical Nitro or Placebo Pre-Cath
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Topical Nitroglycerin Prior to Trans-radial Coronary Angiography a Phase 2 Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
Phase 2 single-center randomized blinded clinical study to assess the safety and efficacy of topical nitroglycerin on ease of TRA during scheduled PCI We will compare topical nitroglycerin to placebo applied prior to planned non-urgent PCI to determine if nitroglycerin is associated with decreased number of arterial puncture attempts made decreased time to radial access and lower crossover rate to TFA Subjects will be randomized to receive either topical nitroglycerin ointment or placebo prior to scheduled PCI There will be 256 subjects enrolled in this study with 11 randomization
Detailed Description:
Percutaneous coronary intervention PCI procedures performed by entering the radial artery or the transradial approach TRA is associated with reduced vascular access site complications bleeding and length of hospital stay as well as greater patient satisfaction when compared to the transfemoral approach One of the major challenges to a successful TRA remains the small size of the radial artery The potential need for larger catheters during PCI has been one factor limiting broader adoption of TRA and a common reason for crossover from TRA to femoral access intraprocedurally Additionally multiple unsuccessful attempts to access the radial artery leads to unnecessary bleeding and may lead to severe arterial vasospasms Nitroglycerin a vasodilator is available in a topical form and may be used prior to PCI to dilate the radial artery and potentially increase the rate of successful TRA
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?:
False
Is an FDA AA801 Violation?:
None