Acute Safety, Deliverability and Efficacy of the Medtroni... | NCT02452736

Studies
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)

NCT02452736

Sponsor

Medtronic Vascular

Status

Completed

Last Update Posted

Apr 7, 2016Estimated

Enrollment

205Actual

Phase

Phase 3

Conditions

Ischemic Heart Disease
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

Interventions

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Aug 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

May 1, 2015

First Submission Date that Met QC Criteria

May 20, 2015

First Posted Date

May 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2016

Last Update Posted Date

Apr 7, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

205Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System	Device		Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Wuhan Asia Heart Hospital		Wuhan	Hubei	430022	China
Nanjing First Hospital

ID	Term
D017202	Myocardial Ischemia
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D003324	Coronary Artery Disease

ID	Term
D006331	Heart Diseases
D014652	Vascular Diseases
D001157	Arterial Occlusive Diseases
D003327	Coronary Disease