- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04951050
TARGET-PREMIER Trail in Evaluating the Safety and Efficacy of the Rapamycin Target Eluting Stent in CAS Treatment (T-P)
November 8, 2023 updated by: Shanghai MicroPort Medical (Group) Co., Ltd.
A Prospective, Multicenter, Single-arm Trail in Evaluating the Safety and Efficacy of the Rapamycin Target Eluting Stent in Patients With Coronary Artery Stenosis
The aim of the TARGET PREMIER trail in to demonstrate the safety and efficacy of the rapamycin target eluting stent in the treatment of subjects with ischemic heart disease (asymptomatic myocardial ischemia , table or unstable angina), with target lesion(s) in coronary arteries with visually estimated reference vessel diameter ≥2.25mm and ≤4.0 mm.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
200 participants with coronary artery stenosis will enrolled in the investigation to receive PCI surgery treatment with rapamycin target eluting stent implantation.
All the participants will get clinical follow-up after PCI surgery within 30 days, 6 months, 9 months, 12 months and 2-5 years, and they will be conducted coronary angiogram at 9th month after PCI to get the data of in-stent late loss which was the main endpoint of the investigation.
The secondary endpoints including device sucess, operation success, clinical sucess, Doce, PoCE, TLR, TVR, MI incident rate, death, stent thrombosis as defined by ARC, stent retraction, MLD, DS and ARB.
The data derived from the investigation will be performed statistic analysis to evaluate whether the clinical outcome meet the PG.
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Meizhou, Guangdong, China, 514000
- Meizhou Peple's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥18 years.
- Patient with an indication for percutaneous coronary intervention (PCI) including silent ischemia (in absence of symptoms a positive functional study or a reversible change in the ECG consistent with ischemia), angina (stable or unstable).
- Subject acceptable candidate for coronary artery bypass surgery (CABG).
- Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule.
Angiographic Inclusion Criteria:
- Treatment up to two target lesions with a maximum of two lesions per epicardial vessel. If there are two target lesions within the same epicardial vessel, the two target lesions must be at least 10mm apart per visual estimation.
- Target lesion(s) must be located in a native coronary artery with a visually estimated diameter stenosis ≥70%, TIMI 1, lesions length ≤36mm. Target vessel must be visually estimated diameter of ≥2.25mm to ≤4.0mm.
- Target lesion must be adequately covered with a single stent.
- Up to two target lesion needed treatment in one target vessel.
- One non-target lesion is allowed prior to enrollment if successful. It should be located at the distal end of the target lesion, and be at lease 10mm apart, when both are in the same epicardial vessel.
Exclusion Criteria:
General Exclusion Criteria:
- Acute myocardial infarction with 1 week or enzyme levels (Creatinkinase or Troponin) demonstrating that either or both enzyme levels have not returned to normal limits at the time of the procedure.
- Target vessel (including branches) PCI within 12 months of the baseline procedure.
- Known congestive heart failure (NYHA III) or left ventricular ejection fraction (LVEF) <30%
- Patient has current unstable arrhythmias.
- Patient has a history of any coronary arteries brachytherapy.
- Planned surgery within 6 months after index procedure.
- Platelet count <100,000 cells/mm3 or >700,000 cells/mm3, white blood cell (WBC) count <3,000 cells/mm3.
- Impaired renal function (serum creatinine >2.0mg/dl) or patient on dialysis.
- Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attribute to cerebral vascular accident (CVA).
- Patient has a history of bleeding diathesis, contraindication to dual antiplatelet therapy (DAPT).
- Known allergy to protocol-required concomitant medications such as aspirin, or clopidogrel, or heparin and the study stent components such as cobalt, nickel, chromium, rapamycin or similar drugs.
- Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint.
- Other serious medical illness with life expectancy less than 1 year (e.g. cancer, congestive heart failure).
- Patient has immunosuppressive or autoimmune disease, and is receiving or scheduled to immunosuppressive therapy.
- A
- Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test with on week before treatment.)
- Women who intend to become pregnant with 12 months after the baseline procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the baseline procedure).
- Patient has received an organ transplant or is on a waiting list for an organ transplant.
- Patient is receiving or scheduled to receive chemotherapy or radiotherapy with 30 days before or any time after the baseline procedure.
- Patient may not be obedient to the clinical investigation plan through the judgment by investigators.
Angiographic Inclusion Criteria:
- Left main artery coronary disease.
- Three-vessel coronary artery disease.
- Target lesion is located in or supplied by an arterial or venous bypass graft.
- In-stent restenosis lesions.
- Patient has additional lesion(s) for which an intervention with 1 year after the index procedure would be required.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Drug eluting stent
|
Rapamycin target eluting stent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
In-stent late loss
Time Frame: 9 months
|
In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA)
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Target Lesion Failure
Time Frame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
|
Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated)
|
30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
|
Any myocardial ischemia (MI)
Time Frame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
|
percentage of participants that had any MI
|
30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
|
Any revascularization
Time Frame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
|
percentage of participants that had any revascularization
|
30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
|
Ischemia-driven TLR
Time Frame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
|
percentage of participants that had Ischemia-driven TLR
|
30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
|
Probable and definite stent thrombosis defined by Academic Research Consortium (ARC)
Time Frame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
|
percentage of participants that had probable and definite stent thrombosis
|
30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
|
Late lumen loss in segment
Time Frame: 9 months
|
Late Lumen Loss in segment at 9 months post-procedure as measured by quantitative coronary angiography (QCA)
|
9 months
|
In-stent and in-segment binary restenosis rate
Time Frame: 9 months
|
percentage of restenosis ≥50% in-stent or in-segment at 9 months post-procedure
|
9 months
|
Device success
Time Frame: 0 day
|
Device Success is defined as a final residual diameter stenosis of <30%, thrombolysis in myocardial infarction (TIMI) 3, by QCA, using the assigned device only
|
0 day
|
Procedure success
Time Frame: During the hospital stay to a maximum of the first seven days post index procedure
|
Procedure Success defined as achievement of a final diameter stenosis of <30%, TIMI 3, by QCA, using any percutaneous method, without the occurrence of death, Q-wave or non-Q-wave MI, or repeat revascularization of the target lesion during the hospital stay.
|
During the hospital stay to a maximum of the first seven days post index procedure
|
Target lesion success
Time Frame: 0 day
|
Target lesion success defined as achievement of a final diameter stenosis of <30%, TIMI 3, by QCA, using any percutaneous method.
|
0 day
|
TLR
Time Frame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
|
Including ischemia driven or non-ischemia driven
|
30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
|
target vessel revascularization (TVR)
Time Frame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
|
Including ischemia driven or non-ischemia driven
|
30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
|
Patient oriented composite endpoint (PoCE)
Time Frame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
|
defined as all death, all MI and any revascularization
|
30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
|
In-stent and in-segment %diameter stenosis (%DS)
Time Frame: 9 months
|
In-stent and in-segment %diameter stenosis (%DS) at 9 months post-procedure as measured by QCA
|
9 months
|
In-stent and in-segment minimum lumen diameter
Time Frame: 9 months
|
In-stent and in-segment minimum lumen diameter at 9 months post-procedure as measured by QCA.
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Zhi Xiong Zhong, MD, Meizhou Peple's Hospital in Guangdong Province
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2022
Primary Completion (Actual)
August 26, 2023
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
June 26, 2021
First Submitted That Met QC Criteria
June 26, 2021
First Posted (Actual)
July 6, 2021
Study Record Updates
Last Update Posted (Estimated)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 8, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pathological Conditions, Anatomical
- Coronary Disease
- Coronary Artery Disease
- Constriction, Pathologic
- Coronary Stenosis
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- D-IC-035
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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