Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-04-13 @ 10:17 PM
Study NCT ID:
NCT03060460
Status:
TERMINATED
Last Update Posted:
2019-04-04
First Post:
2017-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty
Sponsor:
Christian Juhl Terkelsen
Organization:
Study Overview
Official Title:
Randomized Evaluation of Traditional Versus Ultrasound Guided Insertion of Sheath Before Angiography or Angioplasty
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACCESS-II
Brief Summary:
The study evaluates whether routine use of ultrasound for sheath insertion during radial or femoral angiography or angioplasty has any impact on: number of punctures, patient discomfort, procedural length, successfull procedure or ideal vessel puncture.
Detailed Description:
A randomised study with an historical control group.
Initially data on prespecified endpoints are collected for an historical control group of 200 patients (100 radial and 100 femoral procedures). Hereafter 400 patients are randomized to ultrasound guided or conventional sheath insertion (200 radial and 200 femoral procedures).
Only high-volume physicians who have passed a ultrasound course are allowed to include patients.
Initially data on prespecified endpoints are collected for an historical control group of 200 patients (100 radial and 100 femoral procedures). Hereafter 400 patients are randomized to ultrasound guided or conventional sheath insertion (200 radial and 200 femoral procedures).
Only high-volume physicians who have passed a ultrasound course are allowed to include patients.
Study Oversight
Has Oversight DMC:
True
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?: