Aperture Science Medical Devices Evidence overview
Clinical Evidence

Registered clinical study

PIONEER III study record

ClinicalTrials.gov identifier · NCT03168776

PIONEER III evaluated the safety and effectiveness of the Supreme biodegradable-polymer drug-eluting coronary stent against contemporary durable-polymer everolimus-eluting stents.

NCT03168776registry identifier
2:1randomised allocation
74investigational sites
5 yearsplanned follow-up
Evidence summary

Study design

Prospective, multicentre, randomised and single-blind. Patients were assigned in a 2:1 ratio to Supreme DES or a durable-polymer everolimus-eluting stent comparator.

Study population

The trial enrolled patients with acute or chronic coronary syndromes undergoing percutaneous coronary intervention. Full eligibility and exclusion criteria are provided in the registered protocol and primary publication.

Primary endpoint

The 12-month primary endpoint was target-lesion failure: a composite of cardiac death, target-vessel myocardial infarction or clinically driven target-lesion revascularisation.

Programme timeline

The primary paper reports enrolment from October 2017 to July 2019 across sites in North America, Europe and Japan, with follow-up planned through five years.

Clinical documentation

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