NCT03471845

Brief Summary

It is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (PTCA) in de novo lesions amenable to treatment with Resolute Onyx™ Stent System in China.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
591

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Mar 2018Aug 2026

First Submitted

Initial submission to the registry

March 1, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

March 30, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2021

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

March 1, 2018

Last Update Submit

April 17, 2026

Conditions

Ischemic Heart DiseaseStenotic Coronary LesionCardiovascular DiseasesArteriosclerosisCoronary Artery Disease

Keywords

Major Adverse Cardiac Events (MACE)Myocardial Infarction (MI)Late Lumen Loss (LLL)Target Lesion Revascularization (TLR)Target Vessel Revascularization (TVR)Target Vessel Failure (TVF)Target Lesion Failure (TLF)Stent Thrombosis (ST)PERCUTANEOUS CORONARY INTERVENTION (PCI)

Outcome Measures

Primary Outcomes (1)

  • Target Lesion Failure (TLF)

    TLF

    12 months

Secondary Outcomes (15)

  • Device Success

    at the end of the index procedure or during hospital stay:estimated 7 days

  • Lesion Success

    at the end of the index procedure or during hospital stay: estimated 7 days

  • Procedure Success

    at the end of the index procedure or during hospital stay: estimated 7 days

  • Major Adverse Cardiac Events (MACE)

    30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years

  • Death (Cardiac and Non-cardiac)

    30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years

  • +10 more secondary outcomes

Study Arms (1)

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

EXPERIMENTAL

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Interventions

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemDEVICE

Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Location

MeSH Terms

Conditions

Myocardial IschemiaCardiovascular DiseasesArteriosclerosisCoronary Artery DiseaseMyocardial Infarction

Condition Hierarchy (Ancestors)

Heart DiseasesVascular DiseasesArterial Occlusive DiseasesCoronary DiseaseInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Ben He, MD

    Shanghai Chest Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 21, 2018

Study Start

March 30, 2018

Primary Completion

February 24, 2021

Study Completion (Estimated)

August 30, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

CN(1)