Coronary Artery DiseaseBIOSOLVE-IndiaNCT02916485
Safety and Clinical Performance of a Sirolimus-eluting Absorbable Metal Scaffold
A study testing Bioresorbable scaffold in people with Coronary Artery Disease, run by Biotronik AG at 1 site in India.
Trial summary
Assessment of the clinical performance and the safety of the Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold in a cohort of patients in India with de novo coronary artery lesions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Bioresorbable scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2017to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 years and ≤ 80 years of age
- Written subject informed consent available prior to percutaneous coronary intervention (PCI). Remark: Vulnerable subjects may not be enrolled in this trial
- Subject with stable or unstable angina pectoris or documented silent ischemia
- Subject eligible for PCI
- Subject acceptable candidate for coronary artery bypass surgery
- Subject with a maximum of two single de novo lesions in two different major epicardial vessels
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- Reference vessel diameter between 2.7-3.7 mm by visual estimation, depending on the scaffold size used
- Target lesion length ≤ 21 mm by visual estimation, depending on the scaffold size used
- Target lesion stenosis by visual estimation ≥ 50% - < 100% and TIMI flow ≥1
- Eligible for Dual Anti Platelet Therapy (DAPT)
Who cannot join
- Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
- Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment
- Subjects with a ≥2 fold CK level or in absence of CK a ≥3 fold CKMB level above the upper range limit within 24 hours prior to the index procedure
- Left main coronary artery disease
- Three-vessel coronary artery disease at time of procedure
- Thrombus in target vessel
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- Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
- Planned interventional treatment of any non-target vessel within 30 days post-procedure
- Subject is on dialysis
- Planned intervention of the target vessel after the index procedure
- Ostial target lesion (within 3.0 mm of vessel origin)
- Target lesion involves a side branch >2.0 mm in diameter
- Documented left ventricular ejection fraction (LVEF) ≤ 30%
- Heavily calcified lesion
- Target lesion is located in or supplied by an arterial or venous bypass graft
- The target lesion requires treatment with a device other than the pre-dilatation balloon prior to the Magmaris study device placement (including but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
- Unsuccessful pre-dilatation, defined as minimal lumen diameter smaller than the respective crossing profile of the Magmaris study device and angiographic complications (e.g. distal embolization, side branch closure, extensive dissections that can't be covered by a single scaffold), by visual estimation
- Known allergies to: Acetylsalicylic Acid (ASA), Heparin, contrast medium, Sirolimus, Everolimus or similar drugs (i.e., ABT 578, Biolimus, Tacrolimus), PLLA, Silicon Carbide, Magnesium, Yttrium, Neodymium, Zirconium, Gadolinium, Dysprosium, Tantalum
- Impaired renal function (serum creatinine > 2.5 mg/dl or 221 µmol/l) determined within 72 hours prior to index procedure
- Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are not excluded) or has known life limiting immunosuppressive or autoimmune disease (e.g.,human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
- Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
- Life expectancy less than 6 months
- Planned surgery or dental surgical procedure within 6 months after index procedure
- Subject with tortuous vessel that may impair scaffold placement in the region of obstruction or proximal to the lesion
- In the investigators opinion subjects will not be able to comply with the follow-up requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BIOTRONIK - Safety and Clinical Performance Of the Magmaris Drug Eluting Absorbable Metal Scaffold in a Cohort of Patients in India With de Novo Lesions in NatiVE Coronary Arteries
Assessment of the clinical performance and the safety of the Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold in a cohort of patients in India with de novo coronary artery lesions.
Read the detailed description
This is a prospective, multi-centre, single-arm, open label trial to assess the safety and clinical performance of Magmaris Drug Eluting Absorbable Metal Scaffold.
A total of up to 110 patients with de novo lesions in native coronary arteries will be enrolled at up to 8 investigational sites in India.
In-hospital clinical follow-up visits will take place at 1 and 6 months post procedure.
The primary endpoint is target lesion failure (a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction, coronary artery bypass grafting, clinically driven target lesion revascularization) at 1 month post procedure.
- Conditions
- Coronary Artery Disease
- Being tested
- Bioresorbable scaffold
- Keywords
- bioresorbable scaffold, vascular restoration therapy
- 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.
Bioresorbable scaffoldDevice
Also called Sirolimus-eluting resorbable coronary magnesium scaffold, Magmaris
Percutaneous coronary intervention (PCI)
| Study group | Role | What they receive |
|---|---|---|
| Bioresorbable scaffold | Experimental | Percutaneous coronary intervention (PCI) with a sirolimus-eluting resorbable coronary magnesium scaffold Receives: Device: Bioresorbable scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure
TLF is a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), coronary artery bypass graft (CABG), clinically driven target lesion revascularization (TLR)
Measured: 1 month post-procedure
Secondary outcomes (8)
Target lesion failure (TLF)
TLF is a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), coronary artery bypass graft (CABG), clinically driven target lesion revascularization (TLR)
Measured: 6 months post-procedure
Target vessel failure (TVF)
TVF is a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), coronary artery bypass graft (CABG), clinically driven target vessel revascularization (TVR)
Measured: 1 and 6 months post-procedure
Clinically driven target lesion revascularization
Measured: 1 and 6 months post-procedure
Cardiac death
Measured: 1 and 6 months post-procedure
Myocardial infarction
Measured: 1 and 6 months post-procedure
Scaffold thrombosis
Scaffold thrombosis is composite of definite and probable scaffold thrombosis according to ARC definition
Measured: 1 and 6 months post-procedure
Incidence of procedure success
Procedure Success is a composite of achievement of a final diameter stenosis of <30% by visual assessment or on-line quantitative coronary angiography, without the occurrence of death, Q-wave or non-Q-wave MI, or repeat revascularization of the target lesion during the hospital stay (3 days plus or minus 2 days)
Measured: 3 days (plus or minus 2 days)
Incidence of device success
Device Success is a composite of a final residual diameter stenosis of <30% by visual assessment or on-line quantitative coronary angiography, using the assigned device only, successful delivery of the scaffold to the target lesion site in the coronary artery, appropriate scaffold deployment, successful removal of the device, safe removal of the device in case of deployment failure.
Measured: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startJun 2017 (estimated)
- Primary completionFeb 2018 (estimated)
- Study completionSep 2018 (estimated)
Why it stopped: Awaiting National Pharmaceutical Pricing Authority (NPPA) review of ceiling prices for innovative products in India.
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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CBCC-VIBGYOR Research Pvt. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916485
- Sponsor's protocol ID
- C1601
- Acronym
- BIOSOLVE-India
- Status last verified
- Jun 2017
- First submitted
- 23 Sep 2016
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOTRONIK - Safety and Clinical Performance Of the Magmaris Drug Eluting Absorbable Metal Scaffold in a Cohort of Patients in India With de Novo Lesions in NatiVE Coronary Arteries
- ClinicalTrials.gov ID
- NCT02916485
- Acronym / sponsor ID
- BIOSOLVE-India / C1601
- Conditions
- Coronary Artery Disease
- Keywords
- bioresorbable scaffold, vascular restoration therapy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Awaiting National Pharmaceutical Pricing Authority (NPPA) review of ceiling prices for innovative products in India.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Collaborators
- CBCC-VIBGYOR Research Pvt. Ltd.
- Study start
- Jun 2017 (estimated)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 27 Sep 2016 (estimated)
- 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.
Assessment of the clinical performance and the safety of the Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold in a cohort of patients in India with de novo coronary artery lesions.
Detailed description
This is a prospective, multi-centre, single-arm, open label trial to assess the safety and clinical performance of Magmaris Drug Eluting Absorbable Metal Scaffold.
A total of up to 110 patients with de novo lesions in native coronary arteries will be enrolled at up to 8 investigational sites in India.
In-hospital clinical follow-up visits will take place at 1 and 6 months post procedure.
The primary endpoint is target lesion failure (a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction, coronary artery bypass grafting, clinically driven target lesion revascularization) at 1 month post procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bioresorbable scaffold | Experimental | Device: Bioresorbable scaffoldPercutaneous coronary intervention (PCI) with a sirolimus-eluting resorbable coronary magnesium scaffold |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is ≥ 18 years and ≤ 80 years of age
- Written subject informed consent available prior to percutaneous coronary intervention (PCI). Remark: Vulnerable subjects may not be enrolled in this trial
- Subject with stable or unstable angina pectoris or documented silent ischemia
- Subject eligible for PCI
- Subject acceptable candidate for coronary artery bypass surgery
Key exclusion criteria (25 listed)
- Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
- Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment
- Subjects with a ≥2 fold CK level or in absence of CK a ≥3 fold CKMB level above the upper range limit within 24 hours prior to the index procedure
- Left main coronary artery disease
- Three-vessel coronary artery disease at time of procedure
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 |
|---|---|---|
| Bioresorbable scaffoldAlso: Sirolimus-eluting resorbable coronary magnesium scaffold, MagmarisPercutaneous coronary intervention (PCI) | Device | Bioresorbable scaffold |
Primary outcome
Target lesion failure
Time frame: 1 month post-procedure
TLF is a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), coronary artery bypass graft (CABG), clinically driven target lesion revascularization (TLR)
8 secondary outcomes
Target lesion failure (TLF)
Time frame: 6 months post-procedure
Target vessel failure (TVF)
Time frame: 1 and 6 months post-procedure
Clinically driven target lesion revascularization
Time frame: 1 and 6 months post-procedure
Cardiac death
Time frame: 1 and 6 months post-procedure
Myocardial infarction
Time frame: 1 and 6 months post-procedure
Scaffold thrombosis
Time frame: 1 and 6 months post-procedure
Incidence of procedure success
Time frame: 3 days (plus or minus 2 days)
Incidence of device success
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioresorbable scaffold in people with Coronary Artery Disease, run by Biotronik AG at 1 site in India.
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 10 inclusion and 25 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: paused, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
Results are not available in the source record.
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?
Target lesion failure (time frame: 1 month post-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 14 Jun 2017.