Improved method to prevent complications after heart procedures using the radial artery

A Study on the Application of Simple and Improved Radial Artery Compression Method After Transradial Coronary Intervention a Randomized, Controlled Clinical Trial

This study tests a new way to stop complications after heart procedures using the wrist artery to see if it works better than the usual methods.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1568 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: China Medical University, China (other)
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT06787287 on ClinicalTrials.gov

What this trial studies

This study evaluates a modified compression method using thick gauze combined with a hemostatic device to prevent early radial artery occlusion and related vascular complications following transradial coronary interventions. The research focuses on the effectiveness of this approach compared to traditional methods, aiming to reduce the incidence of complications such as hematoma and occlusion. By analyzing patient outcomes, the study seeks to establish a more effective protocol for post-procedural care in patients undergoing coronary interventions through the radial artery.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who are undergoing coronary interventions via a transradial approach.

Not a fit: Patients with a history of radial artery occlusion or certain vascular diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this method could significantly reduce the risk of radial artery occlusion and improve recovery outcomes for patients undergoing coronary interventions.

How similar studies have performed: Previous studies have shown varying success with different compression methods, but this specific approach is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Over 18 years old, regardless of gender;
* Patients undergoing coronary intervention;
* Patients with a transradial approach;
* Voluntarily participate and sign informed consent;

Exclusion Criteria:

* Intraoperative Allen test was positive for all patients;
* The intraoperative Barbeau tests were all D grade radial artery patients;
* Patients with blood or liver diseases;
* Patients with vascular diseases or malformations in the forearm;
* Patients with a history of RAO at baseline of the radial artery on the approach;
* Approach side arteriovenous fistula dialysis patients;
* Patients with subclavian artery occlusive disease (definite medical history or the difference in systolic blood pressure between the two upper limbs is more than 20mmHg);
* Patients who have completed coronary intervention (full heparin);
* Active bleeding at the puncture site before extraction;
* Systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg at closure;
* Pregnant women or patients who are trying to conceive and have family plans;
* Patients whom the investigator deems inappropriate to participate in the clinical trial;

Where this trial is running

Shenyang, Liaoning

• First Hospital of China Medical University — Shenyang, Liaoning, China (RECRUITING)

Study contacts

• Principal investigator: Yingxian Sun — First Hospital of China Medical University
• Study coordinator: Guozhe Sun

Conditions: Coronary Artery Disease, Radial Artery Occlusion, percutaneous coronary intervention, Compression method, Radial artery complication