Coronary Artery DiseaseBIOVITESSENCT03263858
Vascular Implant Safety and Efficacy Study
A study testing Stent in people with Coronary Artery Disease, run by Biotronik CRC Inc. at 5 sites in Switzerland.
Trial summary
Assessment of the safety and clinical performance of a coronary stent system in de novo coronary artery lesions Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 14 Aug 2017to 28 Jan 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is > 18 years and < 85 years old
- Written subject informed consent
- Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients
- Subject is eligible for percutaneous coronary intervention (PCI)
- Subject is acceptable candidate for coronary artery bypass surgery
- Subject is eligible for Dual Anti Platelet Therapy (DAPT)
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- Subjects with a maximum of two single discrete de novo lesions in two separate native coronary arteries that can be treated with the study stent during the index procedure
- Reference vessel diameter of 3.0 mm to 3.8 mm by visual estimation.
- Target lesion length up to 22 mm by visual estimation.
- Target lesion with ≥ 50% and < 100% stenosis by visual estimation
Who cannot join
- Left main coronary artery disease
- Three-vessel coronary artery disease at the time of index procedure
- Angiographic evidence of thrombus in target vessel
- Chronic total occlusion
- Heavily calcified or extremely tortuous lesions that would prevent complete inflation of a pre-dilatation balloon
- Bifurcation lesion requiring side branch intervention, if side branches > 2mm in diameter are involved
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- Ostial lesions (within 5 mm of vessel origin)
- In-stent restenosis
- Lesions with prior treatment with a drug coated balloon (DCB)
- Target lesion is located in or supplied by an arterial or venous bypass graft
- Target lesion requires treatment with. rotational atherectomy
- Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
- Previous treatment of target vessel within 9 months of index-procedure
- Patients with cardiogenic shock
- Documented left ventricular ejection fraction (LVEF) ≤ 30%
- Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
- Hemodynamically unstable NSTEMI or STEMI within 72 hours prior to index procedure
- Cerebrovascular event (within 3 months of index procedure)
- Subject is receiving oral or intravenous immuno-suppressive therapy (inhaled steroids are allowed) or has known life-limiting immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus, but not diabetes mellitus)
- Known allergies to: Acetylsalicylic Acid (ASA), heparin, contrast medium, sirolimus, or similar drugs, exipients or the stent material
- Triple anticoagulation therapy
- Life expectancy less than 1 year
- Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
- Inability to understand or read the informed consent form
- Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
- In the investigators opinion subjects will not be able to comply with the follow-up requirements
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Switzerland5 sites
University Hospital Bern
Bern
Hôpiteaux Universitaires Genève (HUG)
Geneva
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne
Cardiocentro Ticino
Lugano
University Hospital Zürich
Zurich
About this study
Assessment of the safety and clinical performance of a coronary stent system in de novo coronary artery lesions
- Conditions
- Coronary Artery Disease
- Being tested
- Stent
- 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.
StentDevice
Implantation of coronary stent in de novo coronary artery lesions
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 and 2 | Experimental | Not described Receives: Device: Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strut coverage cohort 1
Strut coverage will be assessed by OCT analysis
Measured: 1 month
In stent late lumen loss cohort 2
Late lumen loss with will be assessed by central QCA assessment
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start14 Aug 2017
- Primary completion4 Nov 2019
- Study completion28 Jan 2020
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
- consecutive enrolment of cohort 1 (primary endpoint at 1 month), and cohort 2 (primary endpoint at 9 months)
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik CRC Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotronik AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263858
- Sponsor's protocol ID
- C1606
- Acronym
- BIOVITESSE
- Status last verified
- Jul 2020
- First submitted
- 21 Aug 2017
- Last updated
- 10 Jul 2020
- 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 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Implant Safety and Efficacy Study
- ClinicalTrials.gov ID
- NCT03263858
- Acronym / sponsor ID
- BIOVITESSE / C1606
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Biotronik CRC Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biotronik AG
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 28 Aug 2017 (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.
Assessment of the safety and clinical performance of a coronary stent system in de novo coronary artery lesions
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- consecutive enrolment of cohort 1 (primary endpoint at 1 month), and cohort 2 (primary endpoint at 9 months)
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 and 2 | Experimental | Device: Stent |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is > 18 years and < 85 years old
- Written subject informed consent
- Subjects with stable or unstable angina pectoris or documented silent ischemia or hemodynamically stable NSTEMI patients
- Subject is eligible for percutaneous coronary intervention (PCI)
- Subject is acceptable candidate for coronary artery bypass surgery
Key exclusion criteria (26 listed)
- Left main coronary artery disease
- Three-vessel coronary artery disease at the time of index procedure
- Angiographic evidence of thrombus in target vessel
- Chronic total occlusion
- Heavily calcified or extremely tortuous lesions that would prevent complete inflation of a pre-dilatation balloon
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 |
|---|---|---|
| StentImplantation of coronary stent in de novo coronary artery lesions | Device | Cohort 1 and 2 |
Primary outcome
Strut coverage cohort 1
Time frame: 1 month
Strut coverage will be assessed by OCT analysis
In stent late lumen loss cohort 2
Time frame: 9 months
Late lumen loss with will be assessed by central QCA assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent in people with Coronary Artery Disease, run by Biotronik CRC Inc. at 5 sites in Switzerland.
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 26 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: finished, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Strut coverage cohort 1 (time frame: 1 month). The study lists 2 primary outcomes in all. 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 10 Jul 2020.