ALPHA LONG Study- BioMatrix AlphaTM Stent Study in Patients With CAD

Launched by BIOSENSORS EUROPE SA · Mar 23, 2023

Keywords

ClinConnect Summary

The ALPHA LONG Study is a clinical trial that aims to evaluate the BioMatrix Alpha™ stent in patients with coronary artery disease (CAD). The study is looking to enroll 85 participants across several centers in Europe. If you are at least 18 years old, scheduled for a procedure called percutaneous coronary intervention (PCI) to treat a specific type of blockage in your heart, and can commit to follow-up visits, you may be eligible to participate. It’s important that you can also take certain medications, like aspirin and clopidogrel, for at least six months after the procedure.

Participants in this trial will be monitored for nine months to see how well the BioMatrix Alpha™ stent works in improving heart health. You’ll be part of a study that compares your results with those from a previous registry study, which will help researchers understand the stent's effectiveness better. If you decide to join, you’ll receive detailed information and support throughout the process, ensuring you know what to expect every step of the way.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients must provide written informed consent
• • 2. Patient is at least 18 years old
• • 3. Patients scheduled to undergo PCI of a de novo lesion(s) with reference vessel diameter and lesion length suitable for treatment with at least one study device
• • 4. Patients who agree to comply with the follow up requirements
• • 5. Patients with a life expectancy of \> 1 year at time of consent
• • 6. Patients eligible to receive for ≥6 months either dual anti-platelet therapy (DAPT, i.e. 75 mg clopidogrel or another P2Y12 inhibitor per choice of the investigator, and 75-100 mg aspirin) or a combination of an oral anti-coagulant (Vitamin K antagonist or novel anti-coagulant) and a single anti-platelet agent
• • 7. Hemodynamically stable patients
• Exclusion Criteria:
• • 1. Inability to provide informed consent
• • 2. Currently participating in another clinical trial
• • 3. Planned surgery ≤6 months of PCI unless DAPT or combination anti-thrombotic/anti-platelet therapy is maintained throughout the peri-surgical period
• • 4. Planned use of additional stents other than BioMatrix AlphaTM during the index procedure.
• • 5. Patients with a life expectancy of \< 1 year
• • 6. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated