CompletedPhase 4

DynamX Bioadaptor Hong Kong Registry

China50 participantsStarted 2020-09-30

Plain-language summary

Prospective, non-randomized, multicenter registry

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject age ≥ 18 and ≤ 80 years
. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
. Indication for a percutaneous intervention with stent implantation in native epicardial arteries including patients with stable coronary artery disease and acute coronary syndromes (non-ST-elevated myocardial infarction)
. Vessel diameter (2.25-3.5 mm) and lesions length ≤ 34 mm suitable for implantation using a single stent per lesion
. All lesions requiring PCI should be amendable for implantation with the study stent
. Successful pre-dilatation of the first lesion defined as no waist in the inflated pre-dilatation balloon using two orthogonal views using a pre- dilatation balloon diameter size ranging from the reference vessel diameter to 0.25 mm smaller than the reference vessel diameter, and a residual diameter stenosis prior to study device implantation by visual estimate being \< 35%

Exclusion criteria

. Target lesion / vessel specific
. Lesions in the left main
. Venous or arterial bypass grafts

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acute Device Success

Timeframe: Immediately after final stent placement (intraprocedure)

Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR).

Timeframe: 12 Months

Trial details

NCT IDNCT04483791

SponsorElixir Medical Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-31

Results submitted2024-09-17

View on ClinicalTrials.gov More Coronary Artery Disease trials