RESOLUTE ONYX China Single Arm Study

• ClinicalTrials.gov Identifier: NCT03471845
• Recruitment Status: Active, not recruiting
• First Posted: March 21, 2018
• Last Update Posted: October 14, 2021
• Sponsor: Medtronic Vascular
• Information provided by (Responsible Party): Medtronic Vascular

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ischemic Heart Disease; Stenotic Coronary Lesion; Cardiovascular Diseases; Arteriosclerosis; Coronary Artery Disease	Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System	Not Applicable

Detailed Description:

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 591 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: March 30, 2018
• Actual Primary Completion Date: February 24, 2021
• Estimated Study Completion Date: October 2, 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System; Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System	Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System; Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements

Outcome Measures

Primary Outcome Measures :

1. Target Lesion Failure (TLF) [ Time Frame: 12 months ]
   TLF

Secondary Outcome Measures :

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 the assigned device only. These measurements will be made by the independent angiographic core laboratory.

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 the assigned device only. These measurements will be made by the independent angiographic core laboratory.

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), emergent coronary bypass surgery, 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

China, Jiangsu

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Sponsors and Collaborators

Medtronic Vascular

Investigators

• Principal Investigator: Ben He, MD; Shanghai Chest Hospital

More Information

• Responsible Party: Medtronic Vascular
• ClinicalTrials.gov Identifier: NCT03471845
• Other Study ID Numbers: MDT16058RES004
• First Posted: March 21, 2018
• Last Update Posted: October 14, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medtronic Vascular:

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)

Additional relevant MeSH terms:

Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Coronary Disease; Arterial Occlusive Diseases; Vascular Diseases