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

August 21, 2025 updated by: Elixir Medical Corporation

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
      • Pölten, Austria
        • Recruiting
        • University Hospital St. Pölten
        • Contact:
          • Julia Mascherbauer, MD
  • Curacao
      • Willemstad, Curacao
        • Recruiting
        • Curaçao Medical Center
        • Contact:
          • Jose Torres, MD
  • Indonesia
      • Jakarta, Indonesia
        • Recruiting
        • Medistra Hospital
        • Contact:
          • Teguh Santoso, MD
      • Jakarta, Indonesia
        • Recruiting
        • Heartology Cardiovascular Hospital
        • Contact:
          • Dafsah Juzar, MD
      • Jakarta, Indonesia
        • Recruiting
        • Jakarta Heart Center
        • Contact:
          • Todung Silalahi, MD
      • Jakarta, Indonesia
        • Recruiting
        • Siloam Hospitals
        • Contact:
          • Antonia Lukito, MD
  • Italy
      • Milan, Italy
        • Recruiting
        • Centro Cardiologico Monzino
        • Contact:
          • Stefano Galli, MD
      • Napoli, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria "Federico II"
        • Contact:
          • Giovanni Esposito, MD
      • Rome, Italy
        • Recruiting
        • Policlinico Tor Vergata
        • Contact:
          • Giuseppe Sangiorgi, MD
  • Jordan
      • Amman, Jordan
        • Recruiting
        • Jordon Hospital
        • Contact:
          • Imad Alhaddad, MD
      • Amman, Jordan
        • Recruiting
        • The Specialty Hospital
        • Contact:
          • Mazen Sudqi, MD
  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • Recruiting
        • King Fahad Armed Forces Hospital
        • Contact:
          • Mirvat Alasnag, MD
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Istanbul Medipol Mega University Hospital
        • Contact:
          • Bilal Boztosun, MD
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Memorial Bahçelievler Hospital
        • Contact:
          • Omer Goktekin, MD
  • United Arab Emirates
      • Sharjah city, United Arab Emirates
        • Recruiting
        • Al Qassimi Hospital
        • Contact:
          • Arif Al Nooryani, MD
  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Recruiting
        • Tam Duc Heart Hospital
        • Contact:
          • Nguyen Huynh Khuong, MD
      • Kiến Giang, Vietnam
        • Recruiting
        • Kiến Giang General Hospital
        • Contact:
          • Huynh Trung Cang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing Percutaneous Coronary Intervention (PCI) who receive at least one DynamX Bioadaptor implant in a commercial setting in accordance with the product's Instructions for Use (IFU).

Description

Inclusion Criteria:

  1. Over 18 years of age
  2. Patient understands the trial requirements and treatment procedures and provides informed consent
  3. 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:

  1. Target Lesion(s) in the left main artery
  2. Prior venous or arterial bypass grafts
  3. In-stent restenosis
  4. 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
  5. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Open Label
DynamX Novolimus-eluting Coronary Bioadaptor System
Device: DynamX Novolimus-eluting Coronary Bioadaptor System
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
In-Hospital, assessed up to 7 days after procedure
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
In-Hospital, assessed up to 7 days after procedure
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
30 days
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.
30 days and 12 months
Rate of target vessel failure (TVF)
Time Frame: 30 days and 12 months
Composite of cardiovascular death, TV-MI, or target vessel revascularization (TVR).
30 days and 12 months
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.
30 days and 12 months
Rate of all MI
Time Frame: 30 days and 12 months
Target and non-target vessel
30 days and 12 months
Rate of all-cause death
Time Frame: 30 days and 12 months
Cardiovascular, Non-Cardiovascular, Unknown
30 days and 12 months
Composite of cardiovascular death, any myocardial infarction, and any revascularization
Time Frame: 30 days and 12 months
30 days and 12 months
Rate of stroke
Time Frame: 30 days and 12 months
30 days and 12 months
Rate of probable or definite stent thrombosis
Time Frame: 30 days and 12 months
30 days and 12 months
Duration of DAPT
Time Frame: 30 days and 12 months
30 days and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Elixir Medical Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ELX-CL-2002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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