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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Coronary Artery Disease; Arteriosclerosis; Ischemic Heart Disease
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Asia Heart Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System; This is a Single arm, Non-randomized Study. All patients meet the eligibility criteria and sign the informed consent form will participate in this study.	Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delivery Success	Defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.	Participants will be followed at the end of index procedure, an expected average of 3 days.
Device Success	defined as the attainment of less than 50% residual stenosis of the target lesion using only the Resolute Integrity stent.	Participants will be followed at the end of index procedure, an expected average of 3 days.
Lesion Success	Defined as the attainment of less than 50% residual stenosis by any percutaneous method.	Participants will be followed at the end of index procedure, an expected average of 3 days.
Procedure Success	Defined as the attainment of less than 50% residual stenosis by any percutaneous method and no in-hospital MACE.	Participants will be followed for the duration of hospital stay, an expected average of 5 days.
In-hospital Major Adverse Cardiac Events (MACE)	Defined as the composite of as in-hospital death, myocardial infarction (Q-wave and non Q-wave), emergent coronary bypass surgery, or repeat target lesion revascularization (TLR; clinically driven/clinically indicated) by percutaneous or surgical method.	Participants will be followed for the duration of hospital stay, an expected average of 5 days.
In-hospital Target Lesion Failure (TLF)	Defined as the composite of cardiac death, myocardial infarction (not clearly attributable to a non-target vessel) or target lesion revascularization (TLR; clinically indicated).	Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Procedure time (min)	Resource Utilization	Participants will be followed at the end of index procedure, an expected average of 3 days.
Contrast volume used (ml)	Resource Utilization	Participants will be followed at the end of index procedure, an expected average of 3 days.
Usage of guiding catheters	Resource Utilization	Participants will be followed at the end of index procedure, an expected average of 3 days.
Usage of guide wires	Resource Utilization	Participants will be followed at the end of index procedure, an expected average of 3 days.
Usage of angioplasty balloons	Resource Utilization	Participants will be followed at the end of index procedure, an expected average of 3 days.

Collaborators and Investigators

• Sponsor: Medtronic Vascular

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 1, 2015
• First Submitted That Met QC Criteria: May 20, 2015
• First Posted (Estimate): May 25, 2015

Study Record Updates

• Last Update Posted (Estimate): April 7, 2016
• Last Update Submitted That Met QC Criteria: April 6, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis
• Other Study ID Numbers: CV-Resolute Integrity China