Arterial Access in Percutaneous Coronary Angiography or Intervention Clinical Trial
— AURAOfficial title:
A Randomized Study of Transradial Versus Transulnar Artery Approach for Coronary Interventions
| Verified date | April 2011 |
| Source | University of Patras |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Greece: Ethics Committee |
| Study type | Interventional |
The transradial route is increasingly used as an access site in percutaneous coronary interventions, as it is considered equivalent to transfemoral approach in terms of efficacy but with a decreased vascular complication risk. Information concerning the efficacy and safety of transulnar approach is sparse. This is a prospective, randomized, investigator-initiated study to compare transradial versus transulnar approach as a default strategy for coronary angiography, ad-hoc or elective percutaneous coronary intervention (PCI). Consecutive eligible patients with an indication for coronary angiography, will be randomized after written informed consent in a 1:1 ratio to either transradial or transulnar access. Assessment of angiographic and procedural characteristics(including amount of contrast medium, arterial access, fluoroscopy and procedural time), as well as any vascular or other peri-procedural complications of the cases enrolled, will be performed. After hospital discharge, all patients will return at Day 60 ±5 days for Doppler ultrasound assessment of the forearm vessels and documentation of major adverse cardiovascular events (defined as death, myocardial infarction, target vessel revascularization and stroke. Coronary angiography patients will be additionally randomized in a 1:1 ratio to either 2500 or 5000 IU of unfractioned heparin.
| Status | Recruiting |
| Enrollment | 572 |
| Est. completion date | September 2011 |
| Est. primary completion date | September 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 19 Years and older |
| Eligibility |
Inclusion Criteria: - Age>18 years - Plan for Coro- and ad hoc PCI, if necessary - Written informed consent Exclusion Criteria: - Cardiogenic shock, haemodynamic instability, Killip class III - Chronic hemodialysis - Coronary artery bypass grafting (CABG) with either bilateral internal mammary artery (IMA) or bilateral radial artery use |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Greece | Patras University Hospital | Patras | Rion |
| Lead Sponsor | Collaborator |
|---|---|
| University of Patras |
Greece,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Successful arterial access free from need for crossover and free from vascular or coronary ischemic complications (MACEs)within 60± days | MACEs are considered both vascular and coronary ischemic complications. Vascular complications include arterial occlusion, local arterial perforation, compartment syndrome, pseudoaneurysm, fistula formation, major bleeding, hematoma of at least 10cm length, or any vascular damage requiring prolonged hospitalization or intervention. Coronary ishcemic complications include cardiac death, non fatal myocardial infarction, urgent repeat revascularization and stroke. |
The primary end point will be assessed within 60±5 days after randomization | Yes |
| Secondary | Fluoroscopy time | Fluoroscopy time (in seconds) assessed within 1 minute after the end of coronary angiography or coronary intervention | Fluoroscopy time will be assessed within 1 minute after the end of coronary angiography or coronary intervention | Yes |
| Secondary | Amount of contrast medium | Volume of contrast medium (ml) will be assessed within 1 minute after the end of coronary angiography or coronary intervention | The amount of contrast medium will be assessed within 1 minute after the end of coronary angiography or coronary intervention | No |
| Secondary | Vascular complication defined as post-procedural occlusion, perforation, pseudo-aneurysm, fistula or hematoma formation | Vascular complication (defined as post-procedural occlusion, perforation, pseudo-aneurysm, fistula or hematoma formation of at least 10 cm length, compartment syndrome) will be assessed 6 hours after the end of coronary angiography or intervention | Vascular complication will be assessed 6 hours after the end of coronary angiography or intervention | Yes |
| Secondary | Procedural duration (defined as the sum of arterial access, coronary angiography and coronary intervention duration) | Procedural duration (defined as the sum of arterial access, coronary angiography and coronary intervention duration)will be assessed within 1 minute after the end of coronary angiography or coronary intervention | Procedural duration will be assessed within 1 minute after the end of coronary angiography or coronary intervention | No |