Clinical trial NCT02452736: Acute Safety, Deliverability and Efficacy of the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Patients According to Indication for Use (CHINA RESOLUTE INTEGRITY STUDY)
Official title: CHINA RESOLUTE INTEGRITY STUDY Acute Safety, Deliverability and Efficacy of the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Patients According to Indication for Use --A Prospective, Multi-center, Single Arm, Non-randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischemic Heart Disease
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2015-05-25
Enrollment: 205
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: The purpose of this study is to conduct a prospective, multi-center, single arm, non-randomized evaluation of acute outcomes in Chinese subjects, including those eligible for percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter of 2.25 mm to 4.0 mm, with the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.

Detailed description: This is a Pre-market, Prospective, Multi-center, Single arm, Non-randomized Study.

The objective of this study is to:

* To assess the deliverability of the Resolute Integrity Stent for suitable patients according to Indication for Use with a reference vessel diameter (RVD) of 2.25 mm to 4.0 mm in 200 evaluable patients
* To assess the in-hospital Major Adverse Cardiac Event (MACE) rate
* To collect data on resource utilization in the catheterization lab. At least 200 evaluable patients from about 15 study centers in China who meet the eligibility criteria and sign the informed consent form will participate in this study.

The expected time of participation in the study for each subject is from informed consent sign-off up to hospital discharge.

An angiographic core laboratory and a Clinical Events Committee (CEC) will be utilized. Adjudication of pre-specified clinical endpoint events will be done by an independent Clinical Events Committee. An angiographic core laboratory will review all baseline, procedural, and clinical event angiograms for all patients.

Eligibility criteria: Inclusion Criteria:

1. Patient is older than or equal to 18 years
2. The patient 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 stent
3. The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form
4. Intention to implant at least one Resolute Integrity stent during percutaneous coronary intervention (PCI)
5. Patient agrees to have all study procedures performed, and is willing to comply with all protocol-required evaluations

Exclusion Criteria:

1. Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, clopidogrel and ticlopidine, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
2. History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
3. A woman who is pregnant, planning to be pregnant or lactating
4. Currently participating in another trial
5. Situation that will prevent dual anti-platelet therapy to be maintained throughout the peri-surgical period
6. Previous enrollment in the China Resolute Integrity Study

Primary outcomes:
measure: Device Specific Procedural Success
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Secondary outcomes:
measure: Delivery Success
timeFrame: Participants will be followed at the end of index procedure, an expected average of 3 days.
measure: Device Success
timeFrame: Participants will be followed at the end of index procedure, an expected average of 3 days.
measure: Lesion Success
timeFrame: Participants will be followed at the end of index procedure, an expected average of 3 days.
measure: Procedure Success
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days.
measure: In-hospital Major Adverse Cardiac Events (MACE)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days.
measure: In-hospital Target Lesion Failure (TLF)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days.
measure: Procedure time (min)
timeFrame: Participants will be followed at the end of index procedure, an expected average of 3 days.
measure: Contrast volume used (ml)
timeFrame: Participants will be followed at the end of index procedure, an expected average of 3 days.
measure: Usage of guiding catheters
timeFrame: Participants will be followed at the end of index procedure, an expected average of 3 days.
measure: Usage of guide wires
timeFrame: Participants will be followed at the end of index procedure, an expected average of 3 days.
measure: Usage of angioplasty balloons
timeFrame: Participants will be followed at the end of index procedure, an expected average of 3 days.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
References: