BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV (BIOSOLVE-IV)

February 9, 2023 updated by: Biotronik AG
The registry will investigate the clinical performance and long-term safety of Magmaris in a real world setting

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (PCI) according to existing guidelines. However, thrombosis and restenosis are still the main limitations of current permanent metallic stents. In contrast to Bare Metal Stents (BMSs), Drug Eluting Stents (DESs) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. However, late and very late stent thrombosis remains the limitation of DES in spite of prolonged dual antiplatelet therapy.Bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents.

The aim of this observational registry is to investigate the clinical performance and long-term safety of Magmaris in a real world setting.

Study Type

Observational

Enrollment (Actual)

2066

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2020
        • ZNA Middelheim Cardiologiy
  • Hong Kong
      • Kowloon, Hong Kong
        • Queen Elizabeth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.

Description

Inclusion cirteria

  1. Subject is ≥18 years of Age
  2. Subject must be willing to sign a Patient Informed Consent (PIC) or Patient Data Release Form (PDRF) where applicable
  3. Symptomatic coronary artery disease
  4. Subject with a maximum of two single de novo lesions in two different major epicardial vessels
  5. Target lesion length ≤21 mm by QCA or by visual estimation
  6. Target lesion stenosis by visual estimation: >50% - <100% and TIMI flow ≥1
  7. Subject is eligible for Dual Anti Platelet Therapy (DAPT)
  8. Reference vessel diameter between 2.7-3.7 mm by visual estimation, depending on the scaffold size used

Exclusion criteria

  1. Pregnant and/or breast feeding females or females who intend to become pregnant during the time of the registry
  2. Known allergies to: Acetylsalicylic Acid (ASA), clopidogrel, ticlopidin, heparin or any other anticoagulant/antiplatelet required for PCI, contrast medium, sirolimus, or similar drugs; or the scaffold materials including Magnesium, Yttrium, Neodymium, Zirconium,Gadolinium, Dysprosium, Tantalum that cannot beadequately pre-medicated
  3. Subjects on dialysis
  4. 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
  5. Documented left ventricular ejection fraction (LVEF) <30%
  6. Restenotic target lesion
  7. Thrombus in target vessel
  8. Target lesion is located in or supplied by a diseased (defined as vessel irregularity per angiogram and >20% stenosed lesion by visual estimation) arterial or venous bypass graft
  9. Left main coronary artery disease
  10. Ostial target lesion (within 5.0 mm of vessel origin)
  11. Target lesion involves a side branch ≥2.0 mm in Diameter
  12. Target vessel (including side branches) has second lesion which requires treatment according to the investigator's discretion
  13. Unsuccessful pre-dilatation, defined as residual Stenosis rate more than 20% measured by QCA and / or angiographic complications (e.g. distal embolization, side branch closure, extensive dissections)
  14. Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
  15. Currently participating in another study and Primary endpoint is not reached yet.
  16. Planned interventional treatment of any target or nontarget vessel

Participating Countries

Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Latvia, Malaysia, New Zealand, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, United Kingdom

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Magmaris
Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
Device: Magmaris
PCI (Magmaris)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Target Lesion Failure (TLF)* at 12 months
Time Frame: 12 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2016

Primary Completion (ACTUAL)

July 14, 2020

Study Completion (ANTICIPATED)

October 1, 2025

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (ESTIMATE)

June 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The primary outcome data will be shared after the publication of it.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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