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BIOSOLVE-IV Magmaris Swiss Satellite Registry

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ClinicalTrials.gov Identifier: NCT04025788
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
IGLESIAS Juan Fernando, University Hospital, Geneva

Brief Summary:
BIOSOLVE-IV Magmaris Swiss Satellite Registry is a prospective, single-arm, multicenter, nationwide open label registry. It is planned to enroll 200 subjects in up to 12 participating sites in Switzerland. After percutaneous coronary intervention (PCI) with the Magmaris scaffold and signature of the informed consent form, all subjects will be followed through hospital discharge and will undergo follow up evaluations at 6, 12 and 24 months post procedure. The follow up evaluations, part of the standard care can be either performed on site (12 months) or by phone (6 and 24 months) and according to routine clinical practice.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: Magmaris Resorbable Magnesium Scaffold (RMS)

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: BIOTRONIKS-Safety and Performance in de Novo Lesion of Native Coronary Arteries With Magmaris (BIOSOLVE)-IV Magmaris Swiss Satellite Registry
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Intervention Details:
  • Device: Magmaris Resorbable Magnesium Scaffold (RMS)
    Subjects will undergo a percutaneous coronary intervention for the implantation of the Magmaris scaffold in accordance with the standard of care and standard hospital practice. Maximum of two single de novo lesions in two separate major epicardial vessels are allowed.


Primary Outcome Measures :
  1. Target Lesion Failure at 12 months [ Time Frame: 12 months ]
    Target Lesion Failure (TLF, a composite of cardiac death, target vessel Q-wave or non-Q wave Myocardial Infarction, and clinically driven Target Lesion Revascularization) at 12 months


Secondary Outcome Measures :
  1. Target Lesion Failure [ Time Frame: 6 months and annually thereafter up to 2 years post-procedure ]
    Target Lesion Failure (TLF) at 6, 12 and 24 months

  2. Clinically driven Target Lesion Revascularization [ Time Frame: 6, 12 months and 24 months post-procedure ]
    Clinically driven Target Lesion Revascularization (TLR) at 6, 12 and 24 months

  3. Clinically driven Target Vessel Revascularization [ Time Frame: 6, 12 months and 24 months post-procedure ]
    Clinically driven Target Vessel Revascularization (TVR) at 6, 12 and 24 months

  4. Cardiac death [ Time Frame: 6, 12 and 24 months post-procedure ]
    Cardiac death at 6, 12 and 24 months

  5. Target Vessel Myocardial Infarction [ Time Frame: 6, 12 and 24 months post-procedure ]
    Target Vessel Myocardial Infarction (MI) at 6, 12 and 24 months

  6. Scaffold thrombosis [ Time Frame: 6, 12 and 24 months post-procedure ]
    Scaffold thrombosis at 6, 12 and 24 months



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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
BIOSOLVE-IV Magmaris Swiss Satellite Registry will include male and female subjects requiring a treatment of de novo coronary artery lesions with Magmaris.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant and/or breastfeeding females or females who intend to become pregnant during the time of the registry
  • Known allergies to: Acetylsalicylic Acid (ASA), clopidogrel, 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 be adequately 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% as documented within maximum 6 months prior to the procedure
  • Heavily calcified or extremely tortuous lesions
  • Bifurcation lesion requiring side branch intervention, if side branches >2 mm in diameter are involved
  • 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 vessel (including side branches) has second lesion which requires treatment according to the investigator`s discretion
  • Unsuccessful pre-dilatation, defined as residual stenosis rate >20% by visual estimation 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
  • Planned interventional treatment of any non-target vessel within 30 days post procedure
  • Planned intervention of the target vessel within 6-month after the index procedure

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): NCT04025788


Contacts
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Contact: Juan F Iglesias, MD +41 79 553 34 67 JuanFernando.Iglesias@hcuge.ch

Locations
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Switzerland
Unité de Cardiologie interventionnelle, Service de cardiologie, Hôpitaux Universitaires de Genève Recruiting
Genève, Switzerland, 1205
Contact: Juan F Iglesias, MD    +41 22 372 72 00    JuanFernando.Iglesias@hcuge.ch   
Contact: Marco Roffi, Prof    +41 22 372 72 00    Marco.Roffi@hcuge.ch   
Kantonsspital Baselland, Kardiologie Recruiting
Liestal, Switzerland, 4410
Contact: Gregor Leibundgut, MD    +41 61 925 23 65    Gregor.Leibundgut@ksbl.ch   
Ensemble Hospitalier de la Côte, Hôpital de Morges, Cardiologie Recruiting
Morges, Switzerland, 1110
Contact: Yann Roux, MD    +41 21 804 21 38    yann.roux@ehc.vd.ch   
Interventionnelle Kardiologie, Kantonspital St.Gallen, Kardiologie Recruiting
Saint Gallen, Switzerland, 9000
Contact: Lucas Joerg, MD    +41 71 494 10 51    Lucas.Joerg@kssg.ch   
Hôpital du Valais Sion Recruiting
Sion, Switzerland, 1950
Contact: Maxime Tapponnier, MD    +41 27 603 45 82    Maxime.tapponnier@hopitalvs.ch   
HFR Fribourg, Cardiologie Recruiting
Villars-sur-Glâne, Switzerland, 1752
Contact: Stéphane Cook, Prof    +41 26 306 38 00    stephane.cook@unifr.ch   
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Juan F Iglesias, MD University Hospital, Geneva

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Responsible Party: IGLESIAS Juan Fernando, Medical Doctor, Principal Investigator, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT04025788     History of Changes
Other Study ID Numbers: 2018-01420
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases