NCT06074549

Brief 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Mar 2024

Longer than P75 for all trials

Geographic Reach
9 countries

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Mar 2024Dec 2028

First Submitted

Initial submission to the registry

September 12, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

March 10, 2024

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

4.7 years

First QC Date

September 12, 2023

Last Update Submit

August 21, 2025

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (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

    12 Months

Secondary Outcomes (12)

  • Clinical Device Success

    In-Hospital, assessed up to 7 days after procedure

  • Clinical Procedural Success

    In-Hospital, assessed up to 7 days after procedure

  • Device Oriented Clinical Endpoint

    30 days

  • Patient Oriented Clinical Endpoint

    30 days and 12 months

  • Rate of target vessel failure (TVF)

    30 days and 12 months

  • +7 more secondary outcomes

Study Arms (1)

Open Label

DynamX Novolimus-eluting Coronary Bioadaptor System

Device: DynamX Novolimus-eluting Coronary Bioadaptor System

Interventions

DynamX Novolimus-eluting Coronary Bioadaptor SystemDEVICE

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

Also known as: DynamX Bioadaptor
Open Label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

University Hospital St. Pölten

Pölten, Austria

RECRUITING

Curaçao Medical Center

Willemstad, Curacao

RECRUITING

Heartology Cardiovascular Hospital

Jakarta, Indonesia

RECRUITING

Jakarta Heart Center

Jakarta, Indonesia

RECRUITING

Medistra Hospital

Jakarta, Indonesia

RECRUITING

Siloam Hospitals

Jakarta, Indonesia

RECRUITING

Centro Cardiologico Monzino

Milan, Italy

RECRUITING

Azienda Ospedaliera Universitaria "Federico II"

Napoli, Italy

RECRUITING

Policlinico Tor Vergata

Rome, Italy

RECRUITING

Jordon Hospital

Amman, Jordan

RECRUITING

The Specialty Hospital

Amman, Jordan

RECRUITING

King Fahad Armed Forces Hospital

Jeddah, Saudi Arabia

RECRUITING

Istanbul Medipol Mega University Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Memorial Bahçelievler Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Al Qassimi Hospital

Sharjah city, United Arab Emirates

RECRUITING

Tam Duc Heart Hospital

Ho Chi Minh City, Vietnam

RECRUITING

Kiến Giang General Hospital

Kiến Giang, Vietnam

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Lisa Tanner

CONTACT

+1 408 636 2000ltanner@ElixirMedical.com

Elizabeth Lau, PhD

CONTACT

elau@ElixirMedical.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2023

First Posted

October 10, 2023

Study Start

March 10, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

August 28, 2025

Record last verified: 2025-08

Locations

VN(2)CU(1)ID(4)AU(1)TU(2)IT(3)AE(1)SA(1)JO(2)