Myocardial InfacrtionNCT02165670
BASIC VALIDATE Coronary Stent Registry
An observational study of Myocardial Infacrtion and Unstable Angina Pectoris, run by Region Örebro County.
Trial summary
BASIC VALIDATE is a coronary stent registry to obtain clinical follow-up information from 2000 patients treated with CE-marked stent (BioMatrix Flex™, Biosensors International) with follow-up of endpoints via the Swedish angiography and angioplasty registry (SCAAR - part of the national SWEDEHEART registry). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Myocardial Infacrtion, Unstable Angina Pectoris, Stable Angina Pectoris
- What is being tested?
- Coronary stenting with CE-marked stent
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Apr 2018
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ischemic heart disease
Who may be able to join
- Patients with a diagnosis of NSTEMI as judged by the physician in accordance with current guideline definitions (positive troponin).
- Patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of ≥0.2 mV in leads V2-V3 and/or ≥0.1 mV in other leads or a probable new-onset left bundle branch block.
- Patients with stable coronary artery disease
- PCI of culprit lesion is intended.
- Age above 18 years
Who cannot join
- Previous participation in the BASIC VALIDATE registry
- Known terminal disease with life expectancy less than one year.
- Patients with known ongoing bleeding
- Patients with uncontrolled hypertension in the opinion of the investigator
- Patients with known subacute bacterial endocarditis
- Patients with known severe renal (GFR < 30 ml/min) and /or liver dysfunctions
- Patients with known thrombocytopenia or thrombocyte function defects
About this study
Official title: BioMatrix NeoFlex Post Marketing Surveillance in Validate (the BASIC VALIDATE) Registry)
BASIC VALIDATE is a coronary stent registry to obtain clinical follow-up information from 2000 patients treated with CE-marked stent (BioMatrix Flex™, Biosensors International) with follow-up of endpoints via the Swedish angiography and angioplasty registry (SCAAR - part of the national SWEDEHEART registry).
Read the detailed description
Purpose of the study The purpose of this registry is to capture clinical data of the BioMatrix NeoFlex™ stent (an improved version of the delivery system of the Biolimus A9™-eluting BioMatrix Flex stent) in relation to safety and effectiveness in the VALIDATE SWEDEHEART trial and in a group of patients not taking part in VALIDATE SWEDEHEART in addition to a group of patients with stable angina pectoris.
Clinical relevance The European Union has a focus on and encourages the conductance of post marketing surveillance studies of medical devices 3. This focus should be seen in the light of limitations to clinical data available in the pre-market phase owing to duration of pre-market clinical investigations, the number of subjects and investigators involved in an investigation, the relative heterogeneity of subjects and investigators and the controlled setting of a clinical investigation versus the full range of clinical conditions encountered in general medical practice. The extent of the data that can be gathered in the pre-market phase does not necessarily enable detection of rare complications or problems that only become apparent after widespread or long term use of the device. Because the study device (BioMatrix NeoFlex™) is a CE-marked updated version of the BioMatrix Flex stent it is important to document that the assumed improvements in delivery design also reflect improvements in a clinical setting.
Patients and methods
Patients A total of 6000 patients will be included in the VALIDATE SWEDEHEART trial. 3000 STEMI and 3000 NSTEMI. The ambition is that approximately 1000 of these patients are also included in the BASIC VALIDATE stent registry. In addition, and in order to achieve post-market information from the entire spectrum of PCI, another 1000 patients with stable angina pectoris, STEMI or NSTEMI will be included in the registry at VALIDATE SWEDEHEART centers but unrelated to the VALIDATE SWEDEHEART trial.
Treatment strategy During the index procedure, only BioMatrix NeoFlex™ stents will be implanted. The investigator will choose the appropriate length and diameter of the stents to be implanted by visual estimate. The choice of the length of the stent should ensure complete coverage of the lesion. In case of insufficient stent expansion, post-dilatation is highly recommended. In the event that a staged procedure is expected or planned it is recommended NOT to include the patient in the BASIC VALIDATE registry because the nature of follow-up of patients (registry only) means that staged procedures will be classified as events ("repeat" revascularizations).
After the index PCI, lifelong acetylsalicylic acid in a dose of 75-160 mg per day will be prescribed. Duration and choice of post-PCI P2Y12 inhibition is left to the discretion of the treating physician.
Endpoints Primary endpoint A composite of time to death, myocardial infarction, stent thrombosis or repeat revascularization at 12 months.
Secondary endpoints
- Time to death at 1, 3 and 5 years.
- Time to myocardial infarction at 1, 3 and 5 years.
- Time to stent thrombosis at 1, 3 and 5 years.
- Time to repeat revascularization at 1, 3 and 5 years.
- Analysis of the primary endpoint in the NSTEMI and STEMI groups separately.
All endpoint results will be compared to matched populations of patients treated with drug-eluting coronary stents as documented in the SCAAR/SWEDEHEART registries.
- Being tested
- Coronary stenting with CE-marked stent
- Keywords
- Ischemic heart disesase, Myocardial infarction, Angina pectoris
- Medical subject headings
- Angina, Unstable, Angina, Stable, Myocardial Infarction, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary stenting with CE-marked stentDevice
Also called BioMatrix Flex™ stent (Biosensors International)
| Study group | Role | What they receive |
|---|---|---|
| Ischemic heart disease | Patients undergoing percutaneous coronary intervention (PCI) Receives: Device: Coronary stenting with CE-marked stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death, MI, Stent Thrombosis, Revascularization
A composite of time to death, myocardial infarction, stent thrombosis or repeat revascularization at 12 months.
Measured: 1 year
Secondary outcomes (1)
Long time Death, AMI, Stent Thrombosis, Revascularization
Time to death at 1, 3 and 5 years, time to myocardial infarction at 1, 3 and 5 years, time to stent thrombosis at 1, 3 and 5 years, time to repeat revascularization at 1, 3 and 5 years.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionApr 2018
- Study completionApr 2018
Why it stopped: After critique raised by peers there was a risk that the study could be interpreted as a marketing tool for a specific product more than a scientific study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfacrtionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Biosensors International
- Responsible party
- Principal investigator, Ole Frobert, MD, PhD, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165670
- Sponsor's protocol ID
- BASIC VALIDATE
- Other IDs
- Prospective registry
- Status last verified
- Mar 2023
- First submitted
- 13 Jun 2014
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BioMatrix NeoFlex Post Marketing Surveillance in Validate (the BASIC VALIDATE) Registry)
- ClinicalTrials.gov ID
- NCT02165670
- Acronym / sponsor ID
- BASIC VALIDATE
- Keywords
- Ischemic heart disesase, Myocardial infarction, Angina pectoris
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: After critique raised by peers there was a risk that the study could be interpreted as a marketing tool for a specific product more than a scientific study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Biosensors International
- Study start
- Jun 2014
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 17 Jun 2014 (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.
BASIC VALIDATE is a coronary stent registry to obtain clinical follow-up information from 2000 patients treated with CE-marked stent (BioMatrix Flex™, Biosensors International) with follow-up of endpoints via the Swedish angiography and angioplasty registry (SCAAR - part of the national SWEDEHEART registry).
Detailed description
Purpose of the study The purpose of this registry is to capture clinical data of the BioMatrix NeoFlex™ stent (an improved version of the delivery system of the Biolimus A9™-eluting BioMatrix Flex stent) in relation to safety and effectiveness in the VALIDATE SWEDEHEART trial and in a group of patients not taking part in VALIDATE SWEDEHEART in addition to a group of patients with stable angina pectoris.
Clinical relevance The European Union has a focus on and encourages the conductance of post marketing surveillance studies of medical devices 3. This focus should be seen in the light of limitations to clinical data available in the pre-market phase owing to duration of pre-market clinical investigations, the number of subjects and investigators involved in an investigation, the relative heterogeneity of subjects and investigators and the controlled setting of a clinical investigation versus the full range of clinical conditions encountered in general medical practice. The extent of the data that can be gathered in the pre-market phase does not necessarily enable detection of rare complications or problems that only become apparent after widespread or long term use of the device. Because the study device (BioMatrix NeoFlex™) is a CE-marked updated version of the BioMatrix Flex stent it is important to document that the assumed improvements in delivery design also reflect improvements in a clinical setting.
Patients and methods
Patients A total of 6000 patients will be included in the VALIDATE SWEDEHEART trial. 3000 STEMI and 3000 NSTEMI. The ambition is that approximately 1000 of these patients are also included in the BASIC VALIDATE stent registry. In addition, and in order to achieve post-market information from the entire spectrum of PCI, another 1000 patients with stable angina pectoris, STEMI or NSTEMI will be included in the registry at VALIDATE SWEDEHEART centers but unrelated to the VALIDATE SWEDEHEART trial.
Treatment strategy During the index procedure, only BioMatrix NeoFlex™ stents will be implanted. The investigator will choose the appropriate length and diameter of the stents to be implanted by visual estimate. The choice of the length of the stent should ensure complete coverage of the lesion. In case of insufficient stent expansion, post-dilatation is highly recommended. In the event that a staged procedure is expected or planned it is recommended NOT to include the patient in the BASIC VALIDATE registry because the nature of follow-up of patients (registry only) means that staged procedures will be classified as events ("repeat" revascularizations).
After the index PCI, lifelong acetylsalicylic acid in a dose of 75-160 mg per day will be prescribed. Duration and choice of post-PCI P2Y12 inhibition is left to the discretion of the treating physician.
Endpoints Primary endpoint A composite of time to death, myocardial infarction, stent thrombosis or repeat revascularization at 12 months.
Secondary endpoints
- Time to death at 1, 3 and 5 years.
- Time to myocardial infarction at 1, 3 and 5 years.
- Time to stent thrombosis at 1, 3 and 5 years.
- Time to repeat revascularization at 1, 3 and 5 years.
- Analysis of the primary endpoint in the NSTEMI and STEMI groups separately.
All endpoint results will be compared to matched populations of patients treated with drug-eluting coronary stents as documented in the SCAAR/SWEDEHEART registries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ischemic heart disease | – | Device: Coronary stenting with CE-marked stentPatients undergoing percutaneous coronary intervention (PCI) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic heart disease
Key inclusion criteria (5 listed)
- Patients with a diagnosis of NSTEMI as judged by the physician in accordance with current guideline definitions (positive troponin).
- Patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of ≥0.2 mV in leads V2-V3 and/or ≥0.1 mV in other leads or a probable new-onset left bundle branch block.
- Patients with stable coronary artery disease
- PCI of culprit lesion is intended.
- Age above 18 years
Key exclusion criteria (7 listed)
- Previous participation in the BASIC VALIDATE registry
- Known terminal disease with life expectancy less than one year.
- Patients with known ongoing bleeding
- Patients with uncontrolled hypertension in the opinion of the investigator
- Patients with known subacute bacterial endocarditis
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 |
|---|---|---|
| Coronary stenting with CE-marked stentAlso: BioMatrix Flex™ stent (Biosensors International) | Device | Ischemic heart disease |
Primary outcome
Death, MI, Stent Thrombosis, Revascularization
Time frame: 1 year
A composite of time to death, myocardial infarction, stent thrombosis or repeat revascularization at 12 months.
1 secondary outcome
Long time Death, AMI, Stent Thrombosis, Revascularization
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infacrtion and Unstable Angina Pectoris, run by Region Örebro County.
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 5 inclusion and 7 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: withdrawn, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Death, MI, Stent Thrombosis, Revascularization (time frame: 1 year). 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 29 Mar 2023.