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)

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02452736
• Other study ID #: CV-Resolute Integrity China
• Status: Completed
• Phase: Phase 3
• First received: May 1, 2015
• Last updated: April 6, 2016
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu
China	Wuhan Asia Heart Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	Yes
Secondary	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.	Yes
Secondary	Procedure time (min)	Resource Utilization	Participants will be followed at the end of index procedure, an expected average of 3 days.	No
Secondary	Contrast volume used (ml)	Resource Utilization	Participants will be followed at the end of index procedure, an expected average of 3 days.	No
Secondary	Usage of guiding catheters	Resource Utilization	Participants will be followed at the end of index procedure, an expected average of 3 days.	No
Secondary	Usage of guide wires	Resource Utilization	Participants will be followed at the end of index procedure, an expected average of 3 days.	No
Secondary	Usage of angioplasty balloons	Resource Utilization	Participants will be followed at the end of index procedure, an expected average of 3 days.	No