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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02817802
Recruitment Status : Active, not recruiting
First Posted : June 29, 2016
Last Update Posted : February 10, 2023
Sponsor:
Information provided by (Responsible Party):
Biotronik AG

Study Description
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Brief Summary:
The registry will investigate the clinical performance and long-term safety of Magmaris in a real world setting

Condition or disease Intervention/treatment
Coronary Artery Disease Device: Magmaris

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 2066 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: BIOTRONIKS - Safety and Performance in de NOvo Lesion of NatiVE Coronary Arteries With Magmaris- Registry: BIOSOLVE-IV
Actual Study Start Date : August 2016
Actual Primary Completion Date : July 14, 2020
Estimated Study Completion Date : October 2025
Groups and Cohorts
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Group/Cohort Intervention/treatment
Magmaris
Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
 Device: Magmaris
PCI (Magmaris)


Outcome Measures
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Primary Outcome Measures :
  1. Target Lesion Failure (TLF)* at 12 months [ Time Frame: 12 month ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817802


Locations
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Belgium
ZNA Middelheim Cardiologiy
Antwerpen, Belgium, 2020
Hong Kong
Queen Elizabeth Hospital
Kowloon, Hong Kong
Sponsors and Collaborators
Biotronik AG
Investigators
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Principal Investigator: Stefan Verheye, MD Cardiovascular Institute Middelheim, Antwerpen, Belgium
Principal Investigator: Michael Kang-Yin Lee, MD Queen Elizabeth Hospital, Hong Kong
More Information
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Additional Information:

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Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT02817802    
Other Study ID Numbers: C1503
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: February 10, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The primary outcome data will be shared after the publication of it.
Keywords provided by Biotronik AG:
Registry
Magmaris
Coronary Artery Disease
PCI
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases