New stent aims to keep heart arteries open longer

NCT ID NCT03471845

Disease control Sponsor: Medtronic Vascular Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a special stent coated with a drug called zotarolimus to treat people with blocked heart arteries. The stent is placed during a procedure to open the artery and slowly releases medication to prevent re-blockage. About 591 participants in China are being followed to see how safe and effective the stent is over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Zotarolimus-eluting coronary stent system
What this could lead to: If successful, this stent could offer a safe and effective way to treat blocked heart arteries, reducing the need for repeat procedures.
What could go wrong: This is a single-arm study without a comparison group, so results may be less conclusive. Stents carry risks like blood clots or re-narrowing of the artery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

591 people

The number who actually took part.

Started

Mar 2018

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * The subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, and the IB of Resolute Onyx stent. * The subject requires treatment of up to 3 target lesions in up to 2 separate target vessels \[2 target lesions in 1 vessel (including its side branches) and 1 target lesion in a separate vessel (including its side branches)\] amenable to treatment with stents with diameter from 2.25 mm to 5.0 mm Key Exclusion Criteria: * Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated * PCI of the target vessel within 9 months prior to the procedure * Active bleeding * Subjects with a life expectancy of less than 12 months * Participation in another clinical study * Pregnant, or lactating women

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Conditions

The condition(s) this trial relates to.

arteriosclerosis disorder cardiovascular disorder coronary artery disorder coronary stenosis myocardial infarction myocardial ischemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arteriosclerosis Cardiovascular diseases Coronary artery disease Ischemic heart disease Stenotic coronary lesion

New stent aims to keep heart arteries open longer

What the study statuses mean