NCT03466151

Brief Summary

It is a randomized controlled trial to evaluate the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in comparison with the Medtronic Resolute Integrity™ Zotarolimus-Eluting coronary stent system in the treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) in China.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
550

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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%
Apr 2018Jul 2026

First Submitted

Initial submission to the registry

March 1, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

April 12, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2021

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 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)The Randomized Controlled TrialPERCUTANEOUS CORONARY INTERVENTION (PCI)

Outcome Measures

Primary Outcomes (1)

  • In-stent Late lumen loss measured by quantitative coronary angiography (QCA)

    Late lumen loss measured by quantitative coronary angiography (QCA)

    9 months

Secondary Outcomes (14)

  • 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, 1 year, 2 years,3 years, 4 years, 5 years

  • Death (Cardiac and Non-cardiac)

    30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years

  • +9 more secondary outcomes

Study Arms (2)

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

EXPERIMENTAL

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

ACTIVE COMPARATOR

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Device: Resolute Integrity™ 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
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent SystemDEVICE

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

Resolute Integrity™ 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, the IB of Resolute Onyx stent, and the IFU of Resolute Integrity 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 4.0 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 (2)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

Fuwai Hospital, Chinese Academy of Medical Science

Beijing, 100037, 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

  • Yongjian Wu, MD

    Fuwai Hospital, Chinese Academy of Medical Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1:1 Randomization
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 15, 2018

Study Start

April 12, 2018

Primary Completion

February 12, 2021

Study Completion (Estimated)

July 31, 2026

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

CN(2)