Recruiting NCT06074549
DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DynamX Novolimus-eluting Coronary Bioadaptor System.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Curacao, Indonesia, Italy, Jordan +4
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System (Bio-RESTORE)
Overview
The goal of this registry is to confirm the safety, and performance of the DynamX Coronary Bioadaptor System in patients with coronary artery disease.
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.
Interventions
- 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
Primary outcome measures
- Device Oriented Clinical Endpoint [Time frame: 12 Months]
Secondary outcome measures (12)
- Clinical Device Success [Time frame: In-Hospital, assessed up to 7 days after procedure]
- Clinical Procedural Success [Time frame: In-Hospital, assessed up to 7 days after procedure]
- Device Oriented Clinical Endpoint [Time frame: 30 days]
- Patient Oriented Clinical Endpoint [Time frame: 30 days and 12 months]
- Rate of target vessel failure (TVF) [Time frame: 30 days and 12 months]
- Rate of all revascularization [Time frame: 30 days and 12 months]
- Rate of all MI [Time frame: 30 days and 12 months]
- Rate of all-cause death [Time frame: 30 days and 12 months]
- Composite of cardiovascular death, any myocardial infarction, and any revascularization [Time frame: 30 days and 12 months]
- Rate of stroke [Time frame: 30 days and 12 months]
- Rate of probable or definite stent thrombosis [Time frame: 30 days and 12 months]
- Duration of DAPT [Time frame: 30 days and 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Indonesia · 4 centers
- Heartology Cardiovascular Hospital — Jakarta
- Jakarta Heart Center — Jakarta
- Medistra Hospital — Jakarta
- Siloam Hospitals — Jakarta
Italy · 3 centers
- Centro Cardiologico Monzino — Milan
- Azienda Ospedaliera Universitaria "Federico II" — Naples
- Policlinico Tor Vergata — Rome
Jordan · 2 centers
- Jordon Hospital — Amman
- The Specialty Hospital — Amman
Turkey (Türkiye) · 2 centers
- Istanbul Medipol Mega University Hospital — Istanbul
- Memorial Bahçelievler Hospital — Istanbul
Vietnam · 2 centers
- Tam Duc Heart Hospital — Ho Chi Minh City
- Kiến Giang General Hospital — Kiến Giang
Austria · 1 center
- University Hospital St. Pölten — Pölten
Curacao · 1 center
- Curaçao Medical Center — Willemstad
Saudi Arabia · 1 center
- King Fahad Armed Forces Hospital — Jeddah
United Arab Emirates · 1 center
- Al Qassimi Hospital — Sharjah city
Identifiers
NCT: NCT06074549 · ELX-CL-2002