Radial Artery Clinical Trial
— ACCESS-IIIOfficial title:
Randomised Comparison of Oximetry Guided Deflation Versus Traditional Rapid Deflation When Removing the TR-band After Radial Angiography or Angioplasty The Access-III Study
Verified date | May 2022 |
Source | Aarhus University Hospital Skejby |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
After performing a radial angiography/percutaneous coronary intervention (CAG/PCI), the sheath is removed and a compression device is used to achieve hemostasis. Recent studies have indicated that rapid deflation techniques resulting in early removal of the compression device is associated with a low incidence of radial artery occlusion (RAO). The purpose of the present study is to evaluate whether an even faster removal of the compression device can be achieved if using oximetry guided rapid deflation compared to traditional rapid deflation, and whether this is associated with a lower incidence of RAO.
Status | Completed |
Enrollment | 3600 |
Est. completion date | December 10, 2021 |
Est. primary completion date | December 10, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients who are scheduled for radial angiography or angioplasty. - Patients with normal flow in a.ulnaris before the procedure (Barbeau type A or B). - Age > 18 years. - Patients able to cooperate and understand information given by the hospital staff. Exclusion Criteria: - Patients not able to give informed consent. |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of cardiology, Aarhus University Hospital in Skejby | Aarhus |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital Skejby | Terumo Corporation |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | RAO (Reverse Barbeau type D) during index hospitalisation | The reverse Barbeau involves compression of the ulnar artery and evaluation of the radial oximetric waveform. This documents the flow through the radial artery post-hemostasis, were a test result A is an open artery and D is an occluded artery. | Day 1 (Evaluated at time of TR-band removal) | |
Primary | Time from sheath removal to removal of the TR-band | The time period will be recorded in the cath. lab. and in the ward. | Day 1 | |
Primary | Proportion who have the TR-band removed within 90,120 and 180 minutes | Calculated with STATA, statistical software | Day 1 | |
Primary | RAO (Reverse Barbeau type D) at follow-up | The reverse Barbeau involves compression of the ulnar artery and evaluation of the radial oximetric waveform. This documents the flow through the radial artery post-hemostasis, were a test result A is an open artery and D is an occluded artery. | After 1 month | |
Secondary | RAO or subocclusion during index hospitalisation | Evaluated by reverse Barbeau Test (type C+D) were a test result A is an open artery and D is a occluded artery and hence B + C are a subocclusion. | Day 1 (Evaluated at time of TR-band removal) | |
Secondary | Hematoma > 2.5 cm | Development of hematoma is monitored at the ward at time of discharge. | Day 1 (Evaluated at time of discharge) | |
Secondary | Time from sheath removal to discharge | The discharge time is recorded in the patient file | Day 1 | |
Secondary | Discomfort in the arm | The pain numeric rating scale (NRS), on which patients rate their current pain intensity from 0 ("no pain") to 10 ("worst possible pain") | At 1 month and 3 months | |
Secondary | RAO or subocclusion at follow-up | Evaluated by reverse Barbeau Test (type C+D) were a test result A is an open artery and D is a occluded artery and hence B + C are a subocclusion. | At 1 month |
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