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)

Medtronic Vascular205 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

205

Conditions

Ischemic Heart Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days.

Procedure time (min)

Resource Utilization

Time frame: Participants will be followed at the end of index procedure, an expected average of 3 days.

Contrast volume used (ml)

Resource Utilization

Time frame: Participants will be followed at the end of index procedure, an expected average of 3 days.

Usage of guiding catheters

Resource Utilization

Time frame: Participants will be followed at the end of index procedure, an expected average of 3 days.

Usage of guide wires

Resource Utilization

Time frame: Participants will be followed at the end of index procedure, an expected average of 3 days.

Usage of angioplasty balloons

Resource Utilization

Time frame: Participants will be followed at the end of index procedure, an expected average of 3 days.

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)

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes