Who is sponsoring NCT03344653?

NCT03344653 is sponsored by Medtronic Vascular.

What drugs are being tested in NCT03344653?

Interventions in NCT03344653: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Biosensors BioFreedom BA9 Drug Coated Coronary Stent.

What condition does NCT03344653 study?

NCT03344653 studies Coronary Artery Disease.

Is NCT03344653 still recruiting?

NCT03344653 is currently completed. Last updated 2 December 2020.

Last reviewed 2020-12-02 · How we verify

NCT03344653: Onyx ONE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients

Completed NA Last updated 2 December 2020

What this trial tests

NA trial testing Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System in Coronary Artery Disease in 2,000 participants. Completed in 9 October 2020.

Timeline

2 November 2017

Primary endpoint
27 September 2018

9 October 2020

Quick facts

Lead sponsor	Medtronic Vascular
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	2,000
Start date	2 November 2017
Primary completion	27 September 2018
Estimated completion	9 October 2020
Sites	89 locations across Hong Kong, Italy, Malaysia, Ireland, Poland, South Korea, New Zealand, Netherlands

Drugs / interventions tested

Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System
Biosensors BioFreedom BA9 Drug Coated Coronary Stent

Conditions studied

Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Medtronic Vascular — full company profile →

Who can join

18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk.
Windecker S, Latib A, Kedhi E, Kirtane AJ, et al · · 2020 · cited 218× · PMID 32050061 · DOI 10.1056/nejmoa1910021
The Evolving Concept of Dual Antiplatelet Therapy after Percutaneous Coronary Intervention: Focus on Unique Feature of East Asian and "Asian Paradox".
Kang J, Kim HS. · · 2018 · cited 51× · PMID 29968428 · DOI 10.4070/kcj.2018.0166
Risk Burden of Cancer in Patients Treated With Abbreviated Dual Antiplatelet Therapy After PCI: Analysis of Multicenter Controlled High-Bleeding Risk Trials.
Campos CM, Mehran R, Capodanno D, Owen R, et al · · 2024 · cited 17× · PMID 38626080 · DOI 10.1161/circinterventions.122.013000
Polymer-Based Versus Polymer-Free Stents in High Bleeding Risk Patients: Final 2-Year Results From Onyx ONE.
Windecker S, Latib A, Kedhi E, Kirtane AJ, et al · · 2022 · cited 17× · PMID 35680195 · DOI 10.1016/j.jcin.2022.04.010
Dual Antiplatelet Therapy in Patients with High Cardiovascular Risk.
Espinoza C, Mukherjee D. · · 2021 · cited 5× · PMID 36277317 · DOI 10.17925/hi.2021.15.1.26
Antithrombotic Treatment After Coronary Intervention: Agreement and Controversy.
Camarero TG, de la Torre Hernández JM. · · 2020 · cited 4× · PMID 32180829 · DOI 10.15420/ecr.2019.25.2
Two-year results from Onyx ONE clear in patients with high bleeding risk on one-month DAPT with and without intracoronary imaging.
Toth GG, Kandzari DE, Kirtane AJ, Windecker S, et al · · 2024 · cited 1× · PMID 37550123 · DOI 10.1016/j.carrev.2023.07.016

Verify or expand the search:

Other recruiting trials for Coronary Artery Disease

Currently open trials in the same condition.

NCT07399002 — LONG NAGOMI™ PMCF STUDY · recruiting
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NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · recruiting

Other Medtronic Vascular trials

Trials by the same sponsor.

NCT07081243 — Symplicity China Study · recruiting
NCT07115953 — Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension · NA · recruiting
NCT07013929 — Spyral InSight Study · NA · recruiting
NCT06907147 — SPYRAL GEMINI Pilot Study · NA · recruiting
NCT05198674 — SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN · NA · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03344653 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medtronic Vascular
Last refreshed: 2 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03344653.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing