Ischemic Heart DiseasePhase 3NCT02452736
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)
A Phase 3 study testing Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in people with Ischemic Heart Disease and Cardiovascular Diseases, run by Medtronic Vascular at 2 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Cardiovascular Diseases, Arteriosclerosis
- What is being tested?
- Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 2 sitesChina
- Study dates
- May 2015to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
About this study
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
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.
Read the 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.
- Conditions
- Ischemic Heart Disease, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease
- Being tested
- Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
- Medical subject headings
- Myocardial Ischemia, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Procedure time (min)
Resource Utilization
Measured: Participants will be followed at the end of index procedure, an expected average of 3 days.
Contrast volume used (ml)
Resource Utilization
Measured: Participants will be followed at the end of index procedure, an expected average of 3 days.
Usage of guiding catheters
Resource Utilization
Measured: Participants will be followed at the end of index procedure, an expected average of 3 days.
Usage of guide wires
Resource Utilization
Measured: Participants will be followed at the end of index procedure, an expected average of 3 days.
Usage of angioplasty balloons
Resource Utilization
Measured: Participants will be followed at the end of index procedure, an expected average of 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452736
- Sponsor's protocol ID
- CV-Resolute Integrity China
- Status last verified
- Apr 2016
- First submitted
- 1 May 2015
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02452736
- Acronym / sponsor ID
- CV-Resolute Integrity China
- Conditions
- Ischemic Heart Disease, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System | Experimental | Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent SystemThis is a Single arm, Non-randomized Study. All patients meet the eligibility criteria and sign the informed consent form will participate in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System | Device | Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System |
Primary outcome
Device Specific Procedural Success
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days.
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).
11 secondary outcomes
Delivery Success
Time frame: Participants will be followed at the end of index procedure, an expected average of 3 days.
Device Success
Time frame: Participants will be followed at the end of index procedure, an expected average of 3 days.
Lesion Success
Time frame: Participants will be followed at the end of index procedure, an expected average of 3 days.
Procedure Success
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)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days.
In-hospital Target Lesion Failure (TLF)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Procedure time (min)
Time frame: Participants will be followed at the end of index procedure, an expected average of 3 days.
Contrast volume used (ml)
Time frame: Participants will be followed at the end of index procedure, an expected average of 3 days.
Usage of guiding catheters
Time frame: Participants will be followed at the end of index procedure, an expected average of 3 days.
Usage of guide wires
Time frame: Participants will be followed at the end of index procedure, an expected average of 3 days.
Usage of angioplasty balloons
Time frame: Participants will be followed at the end of index procedure, an expected average of 3 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in people with Ischemic Heart Disease and Cardiovascular Diseases, run by Medtronic Vascular at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Specific Procedural Success (time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.