China Resolute Integrity 34/38 mm Study

Not Applicable

Completed

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

• Registration Number: NCT03118531
• Lead Sponsor: Medtronic Vascular

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-13
• Study Start: 2017-04-17
• Study First Posted: 2017-04-18
• Primary Completion: 2018-07-31
• Study Completion: 2023-04-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Coronary Stent	Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)	Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System (34/38 mm)

Primary Outcome Measures

Name	Time	Method
Late lumen loss, in stent	9 months (m)	Late lumen loss measured by quantitative coronary angiography (QCA)

Secondary Outcome Measures

Name	Time	Method
In-stent and in-segment percent diameter stenosis (%DS)	9 months	In-stent and in-segment percent diameter stenosis (%DS)
Death	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years	All death
Major Adverse Cardiac Events (MACE)	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years	Defined as death, myocardial infarction (Q wave and non-Q wave), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods
Target Lesion Failure (TLF)	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years	TLF
Myocardial infarction	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years	All MI, and Target Vessel Myocardial Infarction (TVMI)
Stent Thrombosis (ST)	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years	ST
All revascularizations	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years	Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR
Target Vessel Failure (TVF)	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years	TVF
Device Success	At the end of index procedure, an expected average of 3 days	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.
Lesion Success	At the end of index procedure, an expected average of 3 days	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.
Procedure Success	Duration of hospital stay, an expected average of 5 days	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.
In-stent and in-segment binary restenosis rate	9 months	In-stent and in-segment binary restenosis rate
In-stent and in-segment minimal luminal diameter (MLD)	9 months	In-stent and in-segment minimal luminal diameter (MLD)
In-segment late luminal loss	9 months	In-segment late luminal loss

Trial Locations

Locations (2)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China