Clinical trial NCT03118531: China Resolute Integrity 34/38 mm Study
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Stenotic Coronary Lesion
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease
Keywords: Long Lesion
In-stent Late Lumen Loss (LLL)
Major Adverse Cardiac Events (MACE)
MYOCARDIAL INFARCTION (MI)
TARGET VESSEL REVASCULARIZATION (TVR)
TARGET LESION REVASCULARIZATION (TLR)
Target Vessel Failure (TVF)
Target Lesion Failure (TLF)
Stent Thrombosis (ST)
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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, 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

Primary outcomes:
measure: Late lumen loss, in stent
timeFrame: 9 months (m)
Secondary outcomes:
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
measure: Death
timeFrame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
measure: Myocardial infarction
timeFrame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
measure: All revascularizations
timeFrame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
measure: Target Vessel Failure (TVF)
timeFrame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
measure: Target Lesion Failure (TLF)
timeFrame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
measure: Stent Thrombosis (ST)
timeFrame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
measure: Device Success
timeFrame: At the end of index procedure, an expected average of 3 days
measure: Lesion Success
timeFrame: At the end of index procedure, an expected average of 3 days
measure: Procedure Success
timeFrame: Duration of hospital stay, an expected average of 5 days
measure: In-stent and in-segment percent diameter stenosis (%DS)
timeFrame: 9 months
measure: In-stent and in-segment binary restenosis rate
timeFrame: 9 months
measure: In-stent and in-segment minimal luminal diameter (MLD)
timeFrame: 9 months
measure: In-segment late luminal loss
timeFrame: 9 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Lianglong Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: