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

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: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: DynamX Novolimus-eluting Coronary Bioadaptor System

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: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Lisa Tanner; Phone Number: +1 408 636 2000; Email: ltanner@ElixirMedical.com
• Study Contact Backup: Name: Elizabeth Lau, PhD; Email: elau@ElixirMedical.com

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Device Success	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	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	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	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)	Composite of cardiovascular death, TV-MI, or target vessel revascularization (TVR).	30 days and 12 months
Rate of all revascularization	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	Target and non-target vessel	30 days and 12 months
Rate of all-cause death	Cardiovascular, Non-Cardiovascular, Unknown	30 days and 12 months
Composite of cardiovascular death, any myocardial infarction, and any revascularization		30 days and 12 months
Rate of stroke		30 days and 12 months
Rate of probable or definite stent thrombosis		30 days and 12 months
Duration of DAPT		30 days and 12 months

Collaborators and Investigators

• Sponsor: Elixir Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID 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