AzTrials
AzTrials

Coronary Artery DiseaseBio-RESTORENCT06074549

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

An observational study of Coronary Artery Disease, run by Elixir Medical Corporation at 17 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
DynamX Novolimus-eluting Coronary Bioadaptor System
Type of treatment
Medical device
How many people
5,000 participants
Where
17 sitesin 9 countries
Study dates
10 Mar 2024to Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

17 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Lisa Tanner contact

+1 408 636 2000

ltanner@ElixirMedical.com

Elizabeth Lau, PhD contact

elau@ElixirMedical.com

17 sites in 9 countries

Indonesia4 sites, 4 recruiting

  • Heartology Cardiovascular Hospital

    Jakarta

    Dafsah Juzar, MD

    Recruiting

  • Jakarta Heart Center

    Jakarta

    Todung Silalahi, MD

    Recruiting

  • Medistra Hospital

    Jakarta

    Teguh Santoso, MD

    Recruiting

  • Siloam Hospitals

    Jakarta

    Antonia Lukito, MD

    Recruiting

Other trials in Indonesia

Italy3 sites, 3 recruiting

  • Centro Cardiologico Monzino

    Milan

    Stefano Galli, MD

    Recruiting

  • Azienda Ospedaliera Universitaria "Federico II"

    Naples

    Giovanni Esposito, MD

    Recruiting

  • Policlinico Tor Vergata

    Rome

    Giuseppe Sangiorgi, MD

    Recruiting

Other trials in Italy

Jordan2 sites, 2 recruiting

  • Jordon Hospital

    Amman

    Imad Alhaddad, MD

    Recruiting

  • The Specialty Hospital

    Amman

    Mazen Sudqi, MD

    Recruiting

Other trials in Jordan

Turkey (Türkiye)2 sites, 2 recruiting

  • Istanbul Medipol Mega University Hospital

    Istanbul

    Bilal Boztosun, MD

    Recruiting

  • Memorial Bahçelievler Hospital

    Istanbul

    Omer Goktekin, MD

    Recruiting

Other trials in Turkey (Türkiye)

Vietnam2 sites, 2 recruiting

  • Tam Duc Heart Hospital

    Ho Chi Minh City

    Nguyen Huynh Khuong, MD

    Recruiting

  • Kiến Giang General Hospital

    Kiến Giang

    Huynh Trung Cang, MD

    Recruiting

Other trials in Vietnam

Austria1 site, 1 recruiting

  • University Hospital St. Pölten

    Pölten

    Julia Mascherbauer, MD

    Recruiting

Other trials in Austria

Curacao1 site, 1 recruiting

  • Curaçao Medical Center

    Willemstad

    Jose Torres, MD

    Recruiting
Saudi Arabia1 site, 1 recruiting

  • King Fahad Armed Forces Hospital

    Jeddah

    Mirvat Alasnag, MD

    Recruiting

Other trials in Saudi Arabia

United Arab Emirates1 site, 1 recruiting

  • Al Qassimi Hospital

    Sharjah city

    Arif Al Nooryani, MD

    Recruiting

Other trials in United Arab Emirates

About this study

Official title: 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.

Read the 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.

Being tested
DynamX Novolimus-eluting Coronary Bioadaptor System
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DynamX Novolimus-eluting Coronary Bioadaptor SystemDevice

    Also called DynamX Bioadaptor

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

Study groups in NCT06074549
Study groupRoleWhat they receive
Open LabelDynamX Novolimus-eluting Coronary Bioadaptor System
Receives: Device: DynamX Novolimus-eluting Coronary Bioadaptor System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Device Oriented Clinical Endpoint

    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

    Measured: 12 Months

Secondary outcomes (12)

  1. Clinical Device Success

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

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

  2. Clinical Procedural Success

    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

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

  3. Device Oriented Clinical Endpoint

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

    Measured: 30 days

  4. Patient Oriented Clinical Endpoint

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

    Measured: 30 days and 12 months

  5. Rate of target vessel failure (TVF)

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

    Measured: 30 days and 12 months

  6. Rate of all revascularization

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

    Measured: 30 days and 12 months

  7. Rate of all MI

    Target and non-target vessel

    Measured: 30 days and 12 months

  8. Rate of all-cause death

    Cardiovascular, Non-Cardiovascular, Unknown

    Measured: 30 days and 12 months

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

    Measured: 30 days and 12 months

  10. Rate of stroke

    Measured: 30 days and 12 months

  11. Rate of probable or definite stent thrombosis

    Measured: 30 days and 12 months

  12. Duration of DAPT

    Measured: 30 days and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start10 Mar 2024
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06074549
Sponsor's protocol ID
ELX-CL-2002
Acronym
Bio-RESTORE
Status last verified
Aug 2025
First submitted
12 Sep 2023
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Elixir Medical Corporation at 17 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Indonesia, Italy, Jordan, Turkey (Türkiye), Vietnam and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lisa Tanner (+1 408 636 2000, ltanner@ElixirMedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device Oriented Clinical Endpoint (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06074549.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in