Back to results

RESOLUTE ONYX China RCT Study

Primary Purpose

Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases

Status

Active

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring 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 Trial, PERCUTANEOUS CORONARY INTERVENTION (PCI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, 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

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

Sites / Locations

Shengjing Hospital of China Medical University
Fuwai Hospital, Chinese Academy of Medical Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Arm Description

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Outcomes

Primary Outcome Measures

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

Late lumen loss measured by quantitative coronary angiography (QCA)

Secondary Outcome Measures

Device Success

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.

Lesion Success

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.

Procedure Success

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.

Major Adverse Cardiac Events (MACE)

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

Death (Cardiac and Non-cardiac)

All deaths

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

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

All revascularizations

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

Target Vessel Failure (TVF)

TVF

Target Lesion Failure (TLF)

TLF

Stent Thrombosis (ST)

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

Angiographic measures: In-stent and in-segment percent diameter stenosis (%DS)

In-stent and in-segment binary restenosis rate

Angiographic measures:In-stent and in-segment binary restenosis rate

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

Angiographic measures:In-stent and in-segment minimal luminal diameter (MLD)

In-segment late luminal loss

Angiographic measures: In-segment late luminal loss

Full Information

NCT ID

NCT03466151

First Posted

March 1, 2018

Last Updated

October 9, 2023

Sponsor

Medtronic Vascular

1. Study Identification

Unique Protocol Identification Number

NCT03466151

Brief Title

RESOLUTE ONYX China RCT Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 12, 2018 (Actual)

Primary Completion Date

February 12, 2021 (Actual)

Study Completion Date

September 19, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Vascular

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This study is a pre-Market, prospective, multi-center, open-label, randomized controlled trial. Subjects will be 1:1 randomized and followed through 5 Years (screen, implant procedure(including post-procedure assessment),30-Day, 6 Months, 9 Months (primary endpoint_LLL), and annual assessments from 1-5 years).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary 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 Trial, PERCUTANEOUS CORONARY INTERVENTION (PCI)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

1:1 Randomization

Masking

None (Open Label)

Allocation

Randomized

Enrollment

550 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Arm Type

Experimental

Arm Description

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Arm Title

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Arm Type

Active Comparator

Arm Description

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Intervention Type

Device

Intervention Name(s)

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Late lumen loss measured by quantitative coronary angiography (QCA)

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Device Success

Description

Time Frame

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

Title

Lesion Success

Description

Time Frame

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

Title

Procedure Success

Description

Time Frame

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

Title

Major Adverse Cardiac Events (MACE)

Description

Time Frame