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)
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
1 other identifier
interventional
205
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2015
Shorter than P25 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 7, 2016
April 1, 2016
3 months
May 1, 2015
April 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Device Specific Procedural Success
Defined as device success (the attainment of less than 50% residual stenosis of the target lesion using only the study device) and no in-hospital MACE (composite of death, myocardial infarction, emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization).
Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Secondary Outcomes (11)
Delivery Success
Participants will be followed at the end of index procedure, an expected average of 3 days.
Device Success
Participants will be followed at the end of index procedure, an expected average of 3 days.
Lesion Success
Participants will be followed at the end of index procedure, an expected average of 3 days.
Procedure Success
Participants will be followed for the duration of hospital stay, an expected average of 5 days.
In-hospital Major Adverse Cardiac Events (MACE)
Participants will be followed for the duration of hospital stay, an expected average of 5 days.
- +6 more secondary outcomes
Study Arms (1)
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
EXPERIMENTALThis is a Single arm, Non-randomized Study. All patients meet the eligibility criteria and sign the informed consent form will participate in this study.
Interventions
Eligibility Criteria
You may qualify if:
- Patient is older than or equal to 18 years
- 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
- 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
- Intention to implant at least one Resolute Integrity stent during percutaneous coronary intervention (PCI)
- Patient agrees to have all study procedures performed, and is willing to comply with all protocol-required evaluations
You may not qualify if:
- 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
- History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
- A woman who is pregnant, planning to be pregnant or lactating
- Currently participating in another trial
- Situation that will prevent dual anti-platelet therapy to be maintained throughout the peri-surgical period
- Previous enrollment in the China Resolute Integrity Study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2015
First Posted
May 25, 2015
Study Start
May 1, 2015
Primary Completion
August 1, 2015
Study Completion
December 1, 2015
Last Updated
April 7, 2016
Record last verified: 2016-04