Study 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.
BASIC VALIDATE Coronary Stent Registry
BioMatrix NeoFlex Post Marketing Surveillance in Validate (the BASIC VALIDATE) Registry)
2 other identifiers
observational
N/A
0 countries
N/A
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2014
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 13, 2014
CompletedFirst Posted
Study publicly available on registry
June 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedMarch 29, 2023
March 1, 2023
3.8 years
June 13, 2014
March 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death, MI, Stent Thrombosis, Revascularization
A composite of time to death, myocardial infarction, stent thrombosis or repeat revascularization at 12 months.
1 year
Secondary Outcomes (1)
Long time Death, AMI, Stent Thrombosis, Revascularization
5 years
Study Arms (1)
Ischemic heart disease
Patients undergoing percutaneous coronary intervention (PCI)
Interventions
Eligibility Criteria
Patients with ischemic heart disease
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Örebro Countylead
- Biosensors Internationalcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adjunct Professor, MD, PhD
Study Record Dates
First Submitted
June 13, 2014
First Posted
June 17, 2014
Study Start
June 1, 2014
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
March 29, 2023
Record last verified: 2023-03