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Search / Trial NCT06898021

The 3D Stent Study

Launched by COREAALST BV · Mar 20, 2025

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.

Locations

Patients applied

0 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