Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2025-12-16 @ 10:57 PM
Study NCT ID:
NCT04900987
Status:
None
Last Update Posted:
2022-02-16 00:00:00
First Post:
2021-05-20 00:00:00
Brief Title:
Steri-strips for Reducing Radial Artery Compression Duration
Sponsor:
National Institute of Cardiovascular Diseases Pakistan
Organization:
National Institute of Cardiovascular Diseases, Pakistan
Study Overview
Official Title:
Application of Steri-strips for Reducing the Duration of Post Procedure Radial Artery Compression Via Conventional Pneumatic Transradial Band: An Open-label Randomized Controlled Trial
Status:
None
Status Verified Date:
2022-02
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:
RACC
Brief Summary:
Study population: patients undergoing coronary angiography through transradial approach. Study groups: patients will be randomly assigned in a 1:1 manner to radial arterial compression with conventional pneumatic TR band alone and radial arterial compression with pneumatic TR band mechanical compression with use of clean sterile steri-strips.
Treatment group. Pneumatic TR band compression with use of steri-strips
Control group. Pneumatic TR band compression alone
Method of radial artery compression after sheath removal:
Conventional mechanical compression: Application of pneumatic TR band alone for 4 hours.
Mechanical compression with use of steri-strips: After putting adequate manual pressure proximal to radial puncture site, dry and sterile application of steri-strip followed by pneumatic TR band for 1 hour.
END POINTS:
Primary endpoint will be the time duration of achieving hemostasis with radial artery patency
Secondary endpoint will be Hematoma or Bleeding
Treatment group. Pneumatic TR band compression with use of steri-strips
Control group. Pneumatic TR band compression alone
Method of radial artery compression after sheath removal:
Conventional mechanical compression: Application of pneumatic TR band alone for 4 hours.
Mechanical compression with use of steri-strips: After putting adequate manual pressure proximal to radial puncture site, dry and sterile application of steri-strip followed by pneumatic TR band for 1 hour.
END POINTS:
Primary endpoint will be the time duration of achieving hemostasis with radial artery patency
Secondary endpoint will be Hematoma or Bleeding
Detailed Description:
Study population patients undergoing coronary angiography through transradial approach Study groups patients will be randomly assigned in a 11 manner to radial arterial compression with conventional pneumatic TR band alone and radial arterial compression with pneumatic TR band mechanical compression with use of clean sterile steri-strips
Treatment group Pneumatic TR band compression with use of steri-strips
Control group Pneumatic TR band compression alone
Method of radial artery compression after sheath removal
Conventional mechanical compression Application of pneumatic TR band alone for 4 hours
Mechanical compression with use of steri-strips After putting adequate manual pressure proximal to radial puncture site dry and sterile application of steri-strip followed by pneumatic TR band for 1 hour
END POINTS
Primary endpoint will be the time duration of achieving hemostasis with radial artery patency
Secondary endpoint will be Hematoma or Bleeding
Treatment group Pneumatic TR band compression with use of steri-strips
Control group Pneumatic TR band compression alone
Method of radial artery compression after sheath removal
Conventional mechanical compression Application of pneumatic TR band alone for 4 hours
Mechanical compression with use of steri-strips After putting adequate manual pressure proximal to radial puncture site dry and sterile application of steri-strip followed by pneumatic TR band for 1 hour
END POINTS
Primary endpoint will be the time duration of achieving hemostasis with radial artery patency
Secondary endpoint will be Hematoma or Bleeding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None