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Active, Not Recruiting

NCT Number: NCT03471845

RESOLUTE ONYX China Single Arm Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ischemic Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Stenotic Coronary Lesion Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

About this study

This study is a pre-Market, prospective, multi-center, single arm trial. Subjects will be enrolled and followed through 5 Years (screen, implant procedure(including post-procedure assessment),30-Day, 6 Months, 9 Months-subjects implanted with fringe size, and annual assessments from 1-5 years).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Device

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

Primary outcomes

  1. Target Lesion Failure (TLF)

    Time frame: 12 months

    TLF

Secondary outcomes

  1. Device Success

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

    Definition 1: The attainment of <50% residual stenosis of the target lesion using only the assigned device.

    Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.

  2. Lesion Success

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

    Definition 1: The attainment of <50% residual stenosis of the target lesion using any percutaneous method.

    Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis.

  3. Procedure Success

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

    Definition 1: The attainment of <50% residual stenosis of the target lesion and no in-hospital MACE.

    Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis.

  4. Major Adverse Cardiac Events (MACE)

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

    Defined as composite of death, myocardial infarction (Q wave and non-Q wave), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods

  5. Death (Cardiac and Non-cardiac)

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

    All deaths

  6. Myocardial infarction (all MI, and Target Vessel Myocardial Infarction (TVMI))

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

    All myocardial infarction data will be reported per Medtronic historical protocol definitions.

  7. All revascularizations

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

    Combined endpoints including Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR

  8. Target Vessel Failure (TVF)

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

    TVF

  9. Target Lesion Failure (TLF)

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

    TLF

  10. Stent Thrombosis (ST)

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

    ST

  11. In-stent late luminal loss

    Time frame: 9 months

    Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and In-segment late luminal loss

  12. In-segment late luminal loss

    Time frame: 9 months

    Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and In-segment late luminal loss

  13. In-stent and in-segment percent diameter stenosis (%DS)

    Time frame: 9 months

    Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and in-segment percent diameter stenosis (%DS)

  14. In-stent and in-segment binary restenosis rate

    Time frame: 9 months

    Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and in-segment binary restenosis rate

  15. In-stent and in-segment minimal luminal diameter (MLD)

    Time frame: 9 months

    Only for subjects implanted with certain stent sizes: Angiographic measures:In-stent and in-segment minimal luminal diameter (MLD)

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Registry information

Official study title

A Single Arm Clinical Evaluation of Safety and Efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Subjects Eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) in China

Important dates

Study start
2018
Primary completion
2021
Study completion
2026
First posted
Mar 21, 2018
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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