China Resolute Integrity 34/38 mm Study

Evaluation of the Clinical Safety and Efficacy of the 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Subjects According to the Indication for Use.

To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Arteriosclerosis; Ischemic Heart Disease; Stenotic Coronary Lesion
• Intervention / Treatment: Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Friendship Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

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

Description

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 Instructions for Use of the Resolute Integrity 34/38 mm stent
• The subject can have either a single lesion, or two lesions located in separate target vessels treated during the index procedure. Each lesion length needs to be ≤35mm with at least one lesion length >27mm and≤ 35mm and amenable for treatment with a Resolute Integrity 34/38 mm stent

Key Exclusion Criteria:

• STEMI within 24 hours
• Left main disease
• Bifurcation disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coronary Stent; Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System (34/38 mm)	Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm); The stenting procedure should be performed according to the Instructions for Use that is provided with each 34/38 mm Resolute Integrity stent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late lumen loss, in stent	Late lumen loss measured by quantitative coronary angiography (QCA)	9 months (m)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiac Events (MACE)	Defined as death, myocardial infarction (Q wave and non-Q wave), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Death	All death	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Myocardial infarction	All MI, and Target Vessel Myocardial Infarction (TVMI)	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
All revascularizations	Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Target Vessel Failure (TVF)	TVF	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Target Lesion Failure (TLF)	TLF	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Stent Thrombosis (ST)	ST	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Device Success	The attainment of <50% residual stenosis of the target lesion using only the assigned device. 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.	At the end of index procedure, an expected average of 3 days
Lesion Success	The attainment of <50% residual stenosis of the target lesion using any percutaneous method. 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.	At the end of index procedure, an expected average of 3 days
Procedure Success	The attainment of <50% residual stenosis of the target lesion and no in-hospital MACE. 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.	Duration of hospital stay, an expected average of 5 days
In-stent and in-segment percent diameter stenosis (%DS)	In-stent and in-segment percent diameter stenosis (%DS)	9 months
In-stent and in-segment binary restenosis rate	In-stent and in-segment binary restenosis rate	9 months
In-stent and in-segment minimal luminal diameter (MLD)	In-stent and in-segment minimal luminal diameter (MLD)	9 months
In-segment late luminal loss	In-segment late luminal loss	9 months

Collaborators and Investigators

• Sponsor: Medtronic Vascular
• Investigators: Principal Investigator: Lianglong Chen, MD, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: March 30, 2017
• First Submitted That Met QC Criteria: April 13, 2017
• First Posted (Actual): April 18, 2017

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Target Vessel Failure (TVF); Target Lesion Failure (TLF); Major Adverse Cardiac Events (MACE); Stent Thrombosis (ST); Long Lesion; In-stent Late Lumen Loss (LLL); MYOCARDIAL INFARCTION (MI); TARGET VESSEL REVASCULARIZATION (TVR); TARGET LESION REVASCULARIZATION (TLR)
• Additional Relevant MeSH Terms: Vascular Diseases; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis
• Other Study ID Numbers: MDT16003RES001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No