China Resolute Integrity 34/38 mm Study

Coronary Artery Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118531
• Other study ID #: MDT16003RES001
• Status: Completed
• Phase: N/A
• Start date: April 17, 2017
• Est. completion date: April 28, 2023

Study information

• Verified date: October 2023
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 28, 2023
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia
• Stenotic Coronary Lesion

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing	Beijing
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late lumen loss, in stent	Late lumen loss measured by quantitative coronary angiography (QCA)	9 months (m)
Secondary	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
Secondary	Death	All death	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Secondary	Myocardial infarction	All MI, and Target Vessel Myocardial Infarction (TVMI)	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Secondary	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
Secondary	Target Vessel Failure (TVF)	TVF	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Secondary	Target Lesion Failure (TLF)	TLF	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Secondary	Stent Thrombosis (ST)	ST	30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	In-stent and in-segment percent diameter stenosis (%DS)	In-stent and in-segment percent diameter stenosis (%DS)	9 months
Secondary	In-stent and in-segment binary restenosis rate	In-stent and in-segment binary restenosis rate	9 months
Secondary	In-stent and in-segment minimal luminal diameter (MLD)	In-stent and in-segment minimal luminal diameter (MLD)	9 months
Secondary	In-segment late luminal loss	In-segment late luminal loss	9 months