Bio-RESTORE
Research type
Research Study
Full title
DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Novolimus Eluting Coronary Bioadaptor System
IRAS ID
356457
Contact name
Lisa Tanner
Contact email
Sponsor organisation
Elixir
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 9 months, 1 days
Research summary
The DynamX Global Post-Market Registry is a clinical study that aims to collect real-world data on the safety and effectiveness of the DynamX Coronary Bioadaptor System. This medical device is used to treat people with ischemic heart disease, a condition where narrowed arteries reduce blood flow to the heart. The device is implanted during a procedure called Percutaneous Coronary Intervention (PCI).
The DynamX Bioadaptor is a new type of drug-eluting implant designed to support a blood vessel after treatment and then allow the vessel to regain its natural movement over time. It uses a special design that gradually releases medicine and includes elements that disengage after healing, helping the artery to return to more natural function.
This is an observational registry study that will follow up to 5,000 patients across around 100 hospitals worldwide. All patients will have received at least one DynamX implant. The study does not involve randomisation or comparison groups and is intended to reflect how the device performs in everyday medical practice. Follow-up will include phone calls at 30 days and 12 months after the procedure.
The main goals of the study are to assess the rates of complications such as cardiovascular death, heart attacks, and the need for repeat treatment of the target artery. Additional data will be collected on stroke, stent thrombosis, and overall survival.
Participants must be over 18 years old, suitable for PCI, and able to give informed consent. People with certain heart conditions or who are in other conflicting clinical trials will not be eligible.
The study is sponsored by Elixir Medical and aims to improve understanding of this new technology in routine clinical use.
REC name
London - Stanmore Research Ethics Committee
REC reference
26/LO/0098
Date of REC Opinion
17 Mar 2026
REC opinion
Further Information Favourable Opinion