Ischemic Heart DiseaseNCT03118531
China Resolute Integrity 34/38 mm Study
A study testing Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm) in people with Ischemic Heart Disease and Stenotic Coronary Lesion, run by Medtronic Vascular at 2 sites in China.
Trial summary
To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases
- What is being tested?
- Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 17 Apr 2017to 28 Apr 2023
- Phase
- Interventional
- 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
- The subject 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 34/38 mm stent
- The subject can have either a single lesion, or two lesions located in separate target vessels treated during the index procedure. Each lesion length needs to be ≤35mm with at least one lesion length >27mm and≤ 35mm and amenable for treatment with a Resolute Integrity 34/38 mm stent
Who cannot join
- STEMI within 24 hours
- Left main disease
- Bifurcation disease
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100000
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
About this study
Official title: Evaluation of the Clinical Safety and Efficacy of the 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Subjects According to the Indication for Use.
To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease
- Being tested
- Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)
- Keywords
- Long Lesion, In-stent Late Lumen Loss (LLL), Major Adverse Cardiac Events (MACE), MYOCARDIAL INFARCTION (MI), TARGET VESSEL REVASCULARIZATION (TVR), TARGET LESION REVASCULARIZATION (TLR), Target Vessel Failure (TVF), Target Lesion Failure (TLF), Stent Thrombosis (ST)
- Medical subject headings
- Myocardial Ischemia, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease, Myocardial Infarction
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 System(34/38 mm)Device
The stenting procedure should be performed according to the Instructions for Use that is provided with each 34/38 mm Resolute Integrity stent.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Stent | Experimental | Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System (34/38 mm) Receives: Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late lumen loss, in stent
Late lumen loss measured by quantitative coronary angiography (QCA)
Measured: 9 months (m)
Secondary outcomes (14)
Major Adverse Cardiac Events (MACE)
Defined as death, myocardial infarction (Q wave and non-Q wave), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods
Measured: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Death
All death
Measured: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Myocardial infarction
All MI, and Target Vessel Myocardial Infarction (TVMI)
Measured: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
All revascularizations
Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR
Measured: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Target Vessel Failure (TVF)
TVF
Measured: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Target Lesion Failure (TLF)
TLF
Measured: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Stent Thrombosis (ST)
ST
Measured: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Device Success
The attainment of <50% residual stenosis of the target lesion using only the assigned device.
The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.
Measured: At the end of index procedure, an expected average of 3 days
Lesion Success
The attainment of <50% residual stenosis of the target lesion using any percutaneous method.
The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method. These measurements will be made by the independent angiographic core laboratory.
Measured: At the end of index procedure, an expected average of 3 days
Procedure Success
The attainment of <50% residual stenosis of the target lesion and no in-hospital MACE.
The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory.
Measured: Duration of hospital stay, an expected average of 5 days
In-stent and in-segment percent diameter stenosis (%DS)
In-stent and in-segment percent diameter stenosis (%DS)
Measured: 9 months
In-stent and in-segment binary restenosis rate
In-stent and in-segment binary restenosis rate
Measured: 9 months
In-stent and in-segment minimal luminal diameter (MLD)
In-stent and in-segment minimal luminal diameter (MLD)
Measured: 9 months
In-segment late luminal loss
In-segment late luminal loss
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start17 Apr 2017
- Primary completion31 Jul 2018
- Study completion28 Apr 2023
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lianglong Chen, MD, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118531
- Sponsor's protocol ID
- MDT16003RES001
- Status last verified
- Oct 2023
- First submitted
- 30 Mar 2017
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Safety and Efficacy of the 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Subjects According to the Indication for Use.
- ClinicalTrials.gov ID
- NCT03118531
- Acronym / sponsor ID
- MDT16003RES001
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease
- Keywords
- Long Lesion, In-stent Late Lumen Loss (LLL), Major Adverse Cardiac Events (MACE), MYOCARDIAL INFARCTION (MI), TARGET VESSEL REVASCULARIZATION (TVR), TARGET LESION REVASCULARIZATION (TLR), Target Vessel Failure (TVF), Target Lesion Failure (TLF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 18 Apr 2017 (actual)
- 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.
To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Stent | Experimental | Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System (34/38 mm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The subject 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 34/38 mm stent
- The subject can have either a single lesion, or two lesions located in separate target vessels treated during the index procedure. Each lesion length needs to be ≤35mm with at least one lesion length >27mm and≤ 35mm and amenable for treatment with a Resolute Integrity 34/38 mm stent
Key exclusion criteria (3 listed)
- STEMI within 24 hours
- Left main disease
- Bifurcation disease
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(34/38 mm)The stenting procedure should be performed according to the Instructions for Use that is provided with each 34/38 mm Resolute Integrity stent. | Device | Coronary Stent |
Primary outcome
Late lumen loss, in stent
Time frame: 9 months (m)
Late lumen loss measured by quantitative coronary angiography (QCA)
14 secondary outcomes
Major Adverse Cardiac Events (MACE)
Time frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Death
Time frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Myocardial infarction
Time frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
All revascularizations
Time frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Target Vessel Failure (TVF)
Time frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Target Lesion Failure (TLF)
Time frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Stent Thrombosis (ST)
Time frame: 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years
Device Success
Time frame: At the end of index procedure, an expected average of 3 days
Lesion Success
Time frame: At the end of index procedure, an expected average of 3 days
Procedure Success
Time frame: Duration of hospital stay, an expected average of 5 days
In-stent and in-segment percent diameter stenosis (%DS)
Time frame: 9 months
In-stent and in-segment binary restenosis rate
Time frame: 9 months
In-stent and in-segment minimal luminal diameter (MLD)
Time frame: 9 months
In-segment late luminal loss
Time frame: 9 months
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 10 Oct 2023.
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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.
Lianglong Chen, MD principal investigator
Fujian Medical University Union Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm) in people with Ischemic Heart Disease and Stenotic Coronary Lesion, 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 2 inclusion and 3 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 10 Oct 2023. 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.
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?
Late lumen loss, in stent (time frame: 9 months (m)). 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 10 Oct 2023.