Coronary Artery DiseaseNCT05799963
ALPHA LONG Study- BioMatrix AlphaTM Stent Study in Patients With CAD
A study testing BioMatrix Alpha in people with Coronary Artery Disease, run by Biosensors Europe SA at 9 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- BioMatrix Alpha
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 9 Feb 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to provide informed consent
- Currently participating in another clinical trial
- Planned surgery ≤6 months of PCI unless DAPT or combination anti-thrombotic/anti-platelet therapy is maintained throughout the peri-surgical period
- Planned use of additional stents other than BioMatrix AlphaTM during the index procedure.
- Patients with a life expectancy of < 1 year
- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United Kingdom6 sites
University Hospitals Birmingham (UHB)
Birmingham
Royal Blackburn Hospital
Blackburn, BB2 3HH
Hull University Teaching Hospitals (HUTH)
Hull, HU3 2JZ
United Lincolnshire Hospitals (ULH)
Lincoln
The Grange University Hospital, Newport
Newport
Royal Albert Edward Infirmary
Wigan, WN1 2NN
Germany3 sites
Klinikum Bielefeld
Bielefeld, 33604
Krankenhaus Buchholz
Buchholz, 21244
Klinikum Lippe GmbH
Detmold, 32758
About this study
Official title: 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
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.
Read the detailed description
The objective of this study is to evaluate if PCI performed using the additional sizes of the BioMatrix AlphaTM stent results in similar safety and efficacy outcomes as the currently approved (CE marked) sizes of BioMatrix Alpha.
- Conditions
- Coronary Artery Disease
- Being tested
- BioMatrix Alpha
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioMatrix AlphaDevice
Patient will be treated with BioMatrix Alpha
| Study group | Role | What they receive |
|---|---|---|
| BioMatrix Alpha | Experimental | All patients will receive the BioMatrix Alpha as per treatment. Receives: Device: BioMatrix Alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Target Lesion Failure (TLF)
Primary endpoint is the rate of Target Lesion Failure (TLF) at 9 months defined as cardiovascular death or target vessel myocardial infarction or clinically indicated target lesion revascularization (TLR)
Measured: at 9 months after index procedure
Secondary outcomes (6)
Number of participants with Cardiovascular Death (CD)
Incidence
Measured: at 9 months after index procedure
Number of participants with Target Vessel Myocardial Infarction
Target Vessel Myocardial Infarction (TV-MI)
Measured: at 9 months after index procedure
Number of participants with Clinically indicated Target Lesion Revascularization
Clinically indicated Target Lesion Revascularization (ci-TLR)
Measured: at 9 months after index procedure
Number of participants with Target Vessel Revascularization
Target Vessel Revascularization (TVR)
Measured: at 9 months after index procedure
Number of participants with Stent thrombosis (definite and/or probable)
incidence
Measured: at 9 months after index procedure
Number of of participants with All-cause mortality
incidence
Measured: at 9 months after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start9 Feb 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multi-center, open-label single-arm study. 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.
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosensors Europe SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scot Garg, Professor, Principal investigator, Royal Blackburn Hospital, Haslingden Rd, Blackburn BB2 3HH, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799963
- Sponsor's protocol ID
- 22-EU-03
- Status last verified
- Nov 2024
- First submitted
- 23 Mar 2023
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05799963
- Acronym / sponsor ID
- 22-EU-03
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Biosensors Europe SAIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this study is to evaluate if PCI performed using the additional sizes of the BioMatrix AlphaTM stent results in similar safety and efficacy outcomes as the currently approved (CE marked) sizes of BioMatrix Alpha.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multi-center, open-label single-arm study. 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.
| Arm | Type | Receives |
|---|---|---|
| BioMatrix Alpha | Experimental | Device: BioMatrix AlphaAll patients will receive the BioMatrix Alpha as per treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Inability to provide informed consent
- Currently participating in another clinical trial
- Planned surgery ≤6 months of PCI unless DAPT or combination anti-thrombotic/anti-platelet therapy is maintained throughout the peri-surgical period
- Planned use of additional stents other than BioMatrix AlphaTM during the index procedure.
- Patients with a life expectancy of < 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioMatrix AlphaPatient will be treated with BioMatrix Alpha | Device | BioMatrix Alpha |
Primary outcome
Number of participants with Target Lesion Failure (TLF)
Time frame: at 9 months after index procedure
Primary endpoint is the rate of Target Lesion Failure (TLF) at 9 months defined as cardiovascular death or target vessel myocardial infarction or clinically indicated target lesion revascularization (TLR)
6 secondary outcomes
Number of participants with Cardiovascular Death (CD)
Time frame: at 9 months after index procedure
Number of participants with Target Vessel Myocardial Infarction
Time frame: at 9 months after index procedure
Number of participants with Clinically indicated Target Lesion Revascularization
Time frame: at 9 months after index procedure
Number of participants with Target Vessel Revascularization
Time frame: at 9 months after index procedure
Number of participants with Stent thrombosis (definite and/or probable)
Time frame: at 9 months after index procedure
Number of of participants with All-cause mortality
Time frame: at 9 months after index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scot Garg, Professor principal investigator
Royal Blackburn Hospital, Haslingden Rd, Blackburn BB2 3HH, UK
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioMatrix Alpha in people with Coronary Artery Disease, run by Biosensors Europe SA at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Target Lesion Failure (TLF) (time frame: at 9 months after index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024; AzTrials last refreshed its copy on 5 Nov 2026.