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NCT Number: NCT06074549

DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System

The goal of this registry is to confirm the safety, and performance of the DynamX Coronary Bioadaptor System in patients with coronary artery disease.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital St. Pölten, Pölten, Austria

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About this study

This registry will obtain additional safety, effectiveness, and performance data on the DynamX Coronary Bioadaptor System in the treatment of patients with ischemic heart disease due to de novo native coronary artery lesions in a real-world patient population.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Over 18 years of age
  • Patient understands the trial requirements and treatment procedures and provides informed consent
  • Patient indicated for PCI with stent implantation and receive at least one DynamX Bioadaptor implant in accordance with the product's Instructions for Use (IFU).

Exclusion criteria

  • Target Lesion(s) in the left main artery
  • Prior venous or arterial bypass grafts
  • In-stent restenosis
  • Patient is currently participating in another clinical trial with an investigational device or an investigational drug that has the potential to impact study results (e.g., anti-thrombotic or anti-platelet medications) that has not yet completed its primary endpoint
  • Patient is, in the opinion of the Investigator, unable to comply with the requirements of the study protocol or is unsuitable for the registry for any reason

Treatment and study plan

DynamX Novolimus-eluting Coronary Bioadaptor System

Device

All patients will receive at least one DynamX Bioadaptor implant in a commercial setting in accordance with the product's Instructions for Use

Other names: DynamX Bioadaptor

Primary outcomes

  1. Device Oriented Clinical Endpoint

    Time frame: 12 Months

    Composite of Target Lesion Failure (TLF): cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR), per ARC-2

Secondary outcomes

  1. Clinical Device Success

    Time frame: In-Hospital, assessed up to 7 days after procedure

    Achievement of a final residual stenosis <30% by QCA or visual estimation, using the study device and without a device deficiency

  2. Clinical Procedural Success

    Time frame: In-Hospital, assessed up to 7 days after procedure

    Achievement of a final residual stenosis <30% by QCA or visual estimation, using the study device, with or without any adjunctive devices, and without TLF

  3. Device Oriented Clinical Endpoint

    Time frame: 30 days

    Composite of TLF: cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR), per ARC-2

  4. Patient Oriented Clinical Endpoint

    Time frame: 30 days and 12 months

    Composite of all-cause death, any stroke, any myocardial infarction (MI) (includes non-target vessel territory) and any revascularization.

  5. Rate of target vessel failure (TVF)

    Time frame: 30 days and 12 months

    Composite of cardiovascular death, TV-MI, or target vessel revascularization (TVR).

  6. Rate of all revascularization

    Time frame: 30 days and 12 months

    Target lesion, target vessel, non-target lesion, non-target vessel; clinically driven and non-clinically driven.

  7. Rate of all MI

    Time frame: 30 days and 12 months

    Target and non-target vessel

  8. Rate of all-cause death

    Time frame: 30 days and 12 months

    Cardiovascular, Non-Cardiovascular, Unknown

  9. Composite of cardiovascular death, any myocardial infarction, and any revascularization

    Time frame: 30 days and 12 months

  10. Rate of stroke

    Time frame: 30 days and 12 months

  11. Rate of probable or definite stent thrombosis

    Time frame: 30 days and 12 months

  12. Duration of DAPT

    Time frame: 30 days and 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Lau, PhD

CONTACT

[email protected]

Lisa Tanner

CONTACT

[email protected]

+1 408 636 2000

Sponsors and collaborators

Lead sponsor

Elixir Medical Corporation

Industry

Registry information

Official study title

DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System (Bio-RESTORE)

Acronym: Bio-RESTORE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 10, 2023
Registry last updated
Aug 28, 2025

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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