BASIC VALIDATE Coronary Stent Registry

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).

Study Overview

• Status: Withdrawn
• Conditions: Stable Angina Pectoris; Unstable Angina Pectoris; Myocardial Infacrtion
• Intervention / Treatment: Device: Coronary stenting with CE-marked stent

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with ischemic heart disease

Description

Inclusion Criteria

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ischemic heart disease; Patients undergoing percutaneous coronary intervention (PCI)	Device: Coronary stenting with CE-marked stent; Other Names: BioMatrix Flex™ stent (Biosensors International)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death, MI, Stent Thrombosis, Revascularization	A composite of time to death, myocardial infarction, stent thrombosis or repeat revascularization at 12 months.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years

Collaborators and Investigators

• Sponsor: Region Örebro County
• Collaborators: Biosensors International

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 16, 2014
• First Posted (Estimate): June 17, 2014

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Myocardial infarction; Angina pectoris; Ischemic heart disesase
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable; Angina, Unstable
• Other Study ID Numbers: BASIC VALIDATE; Prospective registry