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

Coronary Artery Disease Clinical Trial

— Bio-RESTORE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074549
• Other study ID #: ELX-CL-2002
• Status: Recruiting
• Start date: March 10, 2024
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: Elixir Medical Corporation
• Contact: Lisa Tanner
• Phone: +1 408 636 2000
• Email: ltanner[@]ElixirMedical.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

This registry will obtain additional safety, effectiveness, and performance data on the DynamX Novolimus-Eluting 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	King Fahad Armed Forces Hospital	Jeddah

Sponsors (1)

Lead Sponsor	Collaborator
Elixir Medical Corporation

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of target vessel failure (TVF)	Composite of cardiovascular death, TV-MI, or target vessel revascularization (TVR).	30 days and 12 months
Secondary	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
Secondary	Rate of all MI	Target and non-target vessel	30 days and 12 months
Secondary	Rate of all-cause death	Cardiovascular, Non-Cardiovascular, Unknown	30 days and 12 months
Secondary	Composite of cardiovascular death, any myocardial infarction, and any revascularization		30 days and 12 months
Secondary	Rate of stroke		30 days and 12 months
Secondary	Rate of probable or definite stent thrombosis		30 days and 12 months
Secondary	Duration of DAPT		30 days and 12 months