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

NCT02817802 | Unknown DMC

• 1 other identifier: C1503
• Study Type: observational
• Target: 2,066
• Locations: 2 countries
• Sites: 2

Brief Summary

The registry will investigate the clinical performance and long-term safety of Magmaris in a real world setting

Conditions

Coronary Artery Disease

Keywords

Registry; Magmaris; Coronary Artery Disease; PCI

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure (TLF)* at 12 months

  12 month

Study Arms (1)

Magmaris

Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold

Device: Magmaris

Interventions

Magmaris DEVICE

PCI (Magmaris)

Magmaris

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• Pregnant and/or breast feeding females or females who intend to become pregnant during the time of the registry
• 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
• Subjects on dialysis
• 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
• Documented left ventricular ejection fraction (LVEF) \<30%
• Restenotic target lesion
• Thrombus in target vessel
• 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
• Left main coronary artery disease
• Ostial target lesion (within 5.0 mm of vessel origin)
• Target lesion involves a side branch ≥2.0 mm in Diameter
• Target vessel (including side branches) has second lesion which requires treatment according to the investigator's discretion
• 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)
• Planned surgery within 6 months of PCI unless dual antiplatelet therapy will be maintained
• Currently participating in another study and Primary endpoint is not reached yet.

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (2)

ZNA Middelheim Cardiologiy

Antwerp, 2020, Belgium

Location

Queen Elizabeth Hospital

Kowloon, Hong Kong

Location

Related Links

• Primary end point of the study

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Stefan Verheye, MD

  Cardiovascular Institute Middelheim, Antwerpen, Belgium

  PRINCIPAL INVESTIGATOR

• Michael Kang-Yin Lee, MD

  Queen Elizabeth Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 29, 2016
• Study Start: August 1, 2016
• Primary Completion: July 14, 2020
• Study Completion: October 1, 2025
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); HK (1)