NCT05799963Active, not recruiting
ALPHA LONG Study- BioMatrix AlphaTM Stent Study in Patients With CAD
A Prospective Multicenter Single Arm Trial to Assess the Safety and Effectiveness of Additional Sizes of the BioMatrix AlphaTM (Cobalt Chromium Biolimus A9TM Drug-eluting Stent) - ALPHA LONG Study
Source: ClinicalTrials.gov · Last updated 5 Nov 2024
Brief summary (registry, in English)
Prospective, multi-center, open-label single-arm study designed to enroll 85 patients in up to 15 centers in up to 3 European countries. All patients will be followed up for 9 months. The "BMX Alpha Registry" study will serve as reference and historic comparator.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 85 (estimated)
- First submitted
- 23 Mar 2023
- Start date
- 9 Feb 2024
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- Biosensors Europe SA
- Diseases
- Coronary artery disease
- NCT number
- NCT05799963
What you commit to
- Study type: Interventional
- Planned participants: 85
- From 9 Feb 2024 to the primary completion date, 31 Jul 2025
- 9 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- Planned surgery ≤6 months of PCI unless DAPT or combination anti-thrombotic/anti-platelet therapy is maintained throughout the peri-surgical period
Other
- Inability to provide informed consent
- Currently participating in another clinical trial
- Planned use of additional stents other than BioMatrix AlphaTM during the index procedure.
- Patients with a life expectancy of \< 1 year
Who the study is looking for
- Patients must provide written informed consent
- Patient is at least 18 years old
- 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
- Patients who agree to comply with the follow up requirements
- Patients with a life expectancy of \> 1 year at time of consent
- 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
- Hemodynamically stable patients
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinikum Bielefeld Coordinator of this site? Confirm its status | Bielefeld | Germany | Unknown status |
| Krankenhaus Buchholz Coordinator of this site? Confirm its status | Buchholz | Germany | Unknown status |
| Klinikum Lippe GmbH Coordinator of this site? Confirm its status | Detmold | Germany | Unknown status |
| University Hospitals Birmingham (UHB) Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Royal Blackburn Hospital Coordinator of this site? Confirm its status | Blackburn | United Kingdom | Unknown status |
| Hull University Teaching Hospitals (HUTH) Coordinator of this site? Confirm its status | Hull | United Kingdom | Unknown status |
| United Lincolnshire Hospitals (ULH) Coordinator of this site? Confirm its status | Lincoln | United Kingdom | Unknown status |
| The Grange University Hospital, Newport Coordinator of this site? Confirm its status | Newport | United Kingdom | Unknown status |
| Royal Albert Edward Infirmary Coordinator of this site? Confirm its status | Wigan | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.