Trial Information
Current as of April 30, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The 3D Stent Study is a research project aimed at understanding how well a new technology called 3D Stent can detect whether a heart stent is properly expanded in patients with coronary artery disease. This condition often requires a procedure called percutaneous coronary intervention (PCI), where a stent is placed in a blocked artery to help improve blood flow. The study will compare the effectiveness of this new 3D Stent technology to traditional imaging methods used during PCI to ensure that the stent is working correctly.
To participate in this study, patients need to be between the ages of 65 and 74 and have certain heart conditions, either chronic (long-term) or acute (sudden) coronary syndromes, that require a PCI procedure guided by intravascular ultrasound (IVUS). However, individuals who are under 18, have specific health issues, or cannot provide consent will not be eligible. While the study is not yet recruiting participants, those who join can expect to help researchers understand how to better assess stent placement, potentially leading to improved treatment options for patients with heart disease in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patient presenting with chronic or acute coronary syndromes (ACS) with a clinical indication for PCI guided by IVUS.
- Exclusion Criteria:
- • 1. Age \<18 years
- • 2. Coronary lesions requiring total stent length \> 48 mm.
- • 3. Body mass index \>35 kg/m2
- • 4. Uncontrolled recurrent ventricular tachycardia
- • 5. Cardiogenic shock
- • 6. Unable to provide written informed consent (IC).
About Coreaalst Bv
Coreaalst BV is a dynamic clinical trial sponsor specializing in the development and management of innovative therapeutic solutions. Committed to advancing healthcare, Coreaalst BV collaborates closely with researchers, healthcare professionals, and regulatory bodies to design and conduct rigorous clinical trials across various therapeutic areas. With a focus on quality, compliance, and patient safety, the organization leverages its expertise to facilitate efficient study execution and contribute to the successful delivery of new treatments to the market. Coreaalst BV is dedicated to fostering collaboration and driving scientific progress to improve patient outcomes globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Carlos Collet Bortone, MD, PhD
Principal Investigator
Cardiovascular Center Aalst
Adriaan Wilgenhof
Principal Investigator
Cardiovascular Center Aalst
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported