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Completed

NCT Number: NCT03027856

The BIFSORB Pilot Study II

The purpose of this study is to investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital

Aarhus N, 8000, Denmark

About this study

Bioresorbable stents are promising in treatment of coronary artery disease. The concept of bifurcation treatment using BRS is particular appealing as struts covering the side branch ostium may resorb over time.

The aim of this study is to investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions.

Hypothesis: treatment of coronary bifurcation lesions using the Magmaris BRS is safe and feasible.

Methods:

The study is a proof-of-concept, prospective, single arm study with inclusion of 20 patients. Planned 1-and 12-month follow-up by optical coherence tomography (OCT) and follow-up for clinical endpoints until 5 years.

Written informed consent is required before the procedure is performed. Eligible patients with a bifurcation lesion are treated by the provisional technique with mandatory jailing of the side branch and provisional opening of side branch ostium by the mini-kiss technique in case of severe pinching or TIMI-flow less than III. Proximal post-dilatation is mandatory. No dilatation beyond the expansion limits of the stent.

At baseline, the target lesion is assessed by OCT before, during and after implantation of the Magmaris BRS. OCT assessment is performed again at 1- and 12-month follow-up, or before if the patient is readmitted with a possible target lesion failure.

The operator is not blinded to the OCT images as pre-PCI images should be used for sizing and positioning of the stent, and procedural OCT images are used to optimize stent implantation before performing final OCT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable angina pectoris
  • Stabilized non-ST elevation myocardial infarction
  • Silent angina pectoris
  • Age > 18 years
  • De novo coronary bifurcation lesion at LAD/diagonal, CX/obtuse marginal or RCA-PDA/posterolateral branch
  • All Medina classes except Medina x.x.1.
  • Diameter of side branch ≥ 2.5 mm
  • Side branch diameter stenosis less than 50%
  • Signed informed consent

Exclusion criteria

  • ST-elevation infarction within 48 hours
  • Expected survival < 1 year
  • Severe heart failure (NYHA≥III)
  • S-creatinine > 120 µmol/L or GFR < 0.45 mL/min per 1.73 m2
  • Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine or sirolimus
  • Unable to cover main vessel lesion with one stent
  • Severe tortuosity
  • Severe calcification

Treatment and study plan

Magmaris

Device

Implantation of a sirolimus eluting bioresorbable magnesium stent

Primary outcomes

  1. Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

    Time frame: 1 month

    Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

  2. Index of adverse vessel wall features by OCT

    Time frame: 1 month

    Index based on: side branch ostial area late loss, strut fracture, uncovered non-side branch apposed stent struts, uncovered stent struts in front of side branch, uncovered stent struts on acquired or persistent malapposed struts, persistent malapposition, max neointimal thickness/area stenosis, cumulated extra stent lumen gain

Secondary outcomes

  1. Optical coherence tomography endpoint: Acute malapposition

    Time frame: Baseline

  2. Optical coherence tomography endpoint: Acquired malapposition

    Time frame: 1 month

  3. Optical coherence tomography endpoint: Persistent malapposition

    Time frame: 1 month

  4. Optical coherence tomography endpoint: Coverage of jailing struts

    Time frame: 1 month

  5. Optical coherence tomography endpoint: Extra stent lumen (including evaginations)

    Time frame: Baseline and 1 month

  6. Optical coherence tomography endpoint: Late stent recoil

    Time frame: 1 month

  7. Optical coherence tomography endpoint: Stent fracture

    Time frame: Baseline and 1 month

  8. Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts

    Time frame: Baseline and 1 month

  9. Optical coherence tomography endpoint: Ostial strut loss

    Time frame: Baseline and 1 month

  10. Optical coherence tomography endpoint: Mean neointimal thickness

    Time frame: 1 month

  11. Optical coherence tomography endpoint: Stent strut coverage

    Time frame: 1 month

  12. Optical coherence tomography endpoint: Minimal luminal area in segmental analysis

    Time frame: Baseline and 1 month

  13. Optical coherence tomography endpoint: Minimal stent area in segmental analysis

    Time frame: Baseline and 1 month

  14. Optical coherence tomography endpoint: Minimum stent expansion area %

    Time frame: Baseline and 1 month

  15. Optical coherence tomography endpoint: Segmental area stenosis

    Time frame: Baseline and 1 month

  16. Optical coherence tomography endpoint: Healing above calcified plaque

    Time frame: 1 month

  17. Optical coherence tomography endpoint: Healing above lipid plaque

    Time frame: 1 month

  18. Optical coherence tomography endpoint: Acute thrombus on struts

    Time frame: Baseline

  19. Optical coherence tomography endpoint: Late thrombus on struts

    Time frame: 1 month

  20. Optical coherence tomography endpoint: Acute expansion

    Time frame: Baseline

    Measured in segments with: 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation

  21. Optical coherence tomography endpoint: Late recoil

    Time frame: 1 month

    Measured in segments with: 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation

  22. Angiographic endpoint: Ostial side branch area stenosis

    Time frame: Baseline and 1 month

  23. Angiographic endpoint: Ostial side branch acute gain after main vessel stenting

    Time frame: Baseline

  24. Angiographic endpoint: Ostial side branch late loss

    Time frame: 1 month

  25. Angiographic endpoint: Ostial distal main vessel area stenosis

    Time frame: Baseline and 1 month

  26. Angiographic endpoint: Ostial distal main vessel acute gain after main vessel stenting

    Time frame: Baseline

  27. Angiographic endpoint: Ostial distal main vessel late loss

    Time frame: 1 month

  28. Angiographic endpoint: Proximal main vessel area stenosis

    Time frame: Baseline and 1 month

  29. Angiographic endpoint: Proximal main vessel acute gain after main vessel stenting

    Time frame: Baseline

  30. Angiographic endpoint: Proximal main vessel late loss

    Time frame: 1 month

  31. Angiographic endpoint: Minimal luminal area of all segments

    Time frame: Baseline and 1 month

  32. Procedural endpoint: Procedure time

    Time frame: Intraoperative

  33. Procedural endpoint: Contrast use in mL

    Time frame: Intraoperative

  34. Procedural endpoint: Fluoroscopy time

    Time frame: Intraoperative

  35. Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

    Time frame: 6 months

    Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

  36. Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

    Time frame: 24 months

    Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

  37. Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

    Time frame: 60 months

    Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

Other outcomes

  1. Clinical endpoint: myocardial infarction

    Time frame: 5 years

  2. Clinical endpoint: target lesion failure

    Time frame: 5 years

  3. Clinical endpoint: target lesion revascularization

    Time frame: 5 years

  4. Clinical endpoint: stent thrombosis

    Time frame: 5 years

  5. Clinical endpoint: cardiac death

    Time frame: 5 years

  6. Clinical endpoint: non-cardiac death

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Registry information

Official study title

A Sirolimus Eluting Bioresorbable Magnesium Stent for Treatment of Coronary Bifurcation Lesions - The BIFSORB Pilot Study II

Acronym: BIFSORB P-II

Important dates

Study start
2016
Primary completion
2019
Study completion
2024
First posted
Jan 23, 2017
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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