Advanced hemostasis and ultrasound-guided puncture versus conventional methods for radial coronary access
Comparing Advanced Hemostasis and Ultrasound-Guided Puncture to Conventional Approaches in Distal Radial Access: A Dual Randomized Pragmatic Trial
NA · Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS · NCT06835829
This trial tests whether using ultrasound-guided puncture and a potassium ferrate hemostatic patch can improve success and reduce bleeding and artery occlusion for adults having coronary angiography or PCI via radial access.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Associazione per lo Studio delle Malattie Cardiovascolari Cardiva ONLUS (other) |
| Locations | 6 sites (Arlon and 5 other locations) |
| Trial ID | NCT06835829 on ClinicalTrials.gov |
What this trial studies
Adults scheduled for coronary angiography or percutaneous coronary intervention are randomized in a pragmatic design to ultrasound-guided versus conventional puncture and to a potassium ferrate hemostatic patch versus standard hemostasis, with procedures performed via distal or conventional radial access as appropriate. Primary outcomes include radial artery occlusion, vascular access-related adverse events, hemostasis duration, and procedural success rates. Key exclusions include acute STEMI, cardiogenic shock, chronic hemodialysis, and anatomical contraindications to radial access. The trial is conducted across regional hospitals in the participating network with follow-up per protocol.
Who should consider this trial
Good fit: Adults (≥18) planned for coronary angiography or PCI with a palpable radial pulse and able to give written informed consent, including patients with chronic coronary syndrome or non-STEMI/unstable angina.
Not a fit: Patients with ST-elevation myocardial infarction, cardiogenic shock, chronic dialysis, anatomical contraindications to radial access, or who cannot consent are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could reduce radial artery occlusion and access-site complications while shortening time to hemostasis for patients undergoing coronary angiography or PCI.
How similar studies have performed: Meta-analyses indicate distal radial access reduces radial artery occlusion and vascular events versus conventional transradial access, but DRA has shown lower puncture success and the combined use of ultrasound guidance with potassium ferrate hemostasis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years. * Patients presenting with CCS or ACS, including unstable angina or NSTEMI. * Patients planned for coronary angiography or PCI. * Patients able to provide written informed consent. * Patient is willing to comply with all study protocol required evaluations. * Palpable radial pulse both at conventional and distal puncture site. * Reverse modified Barbeau test confirming radial artery patency in patients with a history of previous radial artery catheterization. Exclusion Criteria: * Acute ST-segment elevation myocardial infarction. * Cardiogenic shock. * Chronic hemodialysis. * Contraindications to radial access, such as occlusive upper arm peripheral artery disease, or known anatomic variants prohibiting TRA on both sides. * Medical conditions that may cause non-compliance with the study protocol and/or may confound the data interpretation. * Patients unable to provide written informed consent.
Where this trial is running
Arlon and 5 other locations
- Groupe Vivalia, Clinique Saint-Joseph — Arlon, Belgium (RECRUITING)
- CHU Charleroi-Chimay, Marie Curie Hospital — Charleroi, Belgium (RECRUITING)
- CHU Helora, Jolimont Hospital — La Louvière, Belgium (RECRUITING)
- Sant'Eugenio Hospital — Roma, RM, Italy (RECRUITING)
- Sandro Pertini Hospital — Roma, RM, Italy (RECRUITING)
- Mater Salutis Hospital — Legnago, VR, Italy (RECRUITING)
Study contacts
- Study coordinator: Gregory A Sgueglia, MD, PhD
- Email: g.a.sgueglia@gmail.com
- Phone: +390651002864
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Catheterization, Trasnradial access, Distal radial access, Ultrasound guidance, Potassium ferrate, Hemostasis