Clinical trial NCT04951050: TARGET-PREMIER Trail in Evaluating the Safety and Efficacy of the Rapamycin Target Eluting Stent in CAS Treatment
Official title: A Prospective, Multicenter, Single-arm Trail in Evaluating the Safety and Efficacy of the Rapamycin Target Eluting Stent in Patients With Coronary Artery Stenosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Coronary Stenosis
Lead sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years.
2. 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).
3. Subject acceptable candidate for coronary artery bypass surgery (CABG).
4. 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:

1. 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.
2. 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.
3. Target lesion must be adequately covered with a single stent.
4. Up to two target lesion needed treatment in one target vessel.
5. 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:

1. 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.
2. Target vessel (including branches) PCI within 12 months of the baseline procedure.
3. Known congestive heart failure (NYHA III) or left ventricular ejection fraction (LVEF) \<30%
4. Patient has current unstable arrhythmias.
5. Patient has a history of any coronary arteries brachytherapy.
6. Planned surgery within 6 months after index procedure.
7. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3, white blood cell (WBC) count \<3,000 cells/mm3.
8. Impaired renal function (serum creatinine \>2.0mg/dl) or patient on dialysis.
9. Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attribute to cerebral vascular accident (CVA).
10. Patient has a history of bleeding diathesis, contraindication to dual antiplatelet therapy (DAPT).
11. 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.
12. Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint.
13. Other serious medical illness with life expectancy less than 1 year (e.g. cancer, congestive heart failure).
14. Patient has immunosuppressive or autoimmune disease, and is receiving or scheduled to immunosuppressive therapy.
15. A
16. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test with on week before treatment.)
17. 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).
18. Patient has received an organ transplant or is on a waiting list for an organ transplant.
19. Patient is receiving or scheduled to receive chemotherapy or radiotherapy with 30 days before or any time after the baseline procedure.
20. Patient may not be obedient to the clinical investigation plan through the judgment by investigators.

Angiographic Inclusion Criteria:

1. Left main artery coronary disease.
2. Three-vessel coronary artery disease.
3. Target lesion is located in or supplied by an arterial or venous bypass graft.
4. In-stent restenosis lesions.
5. Patient has additional lesion(s) for which an intervention with 1 year after the index procedure would be required.

Primary outcomes:
measure: In-stent late loss
timeFrame: 9 months
Secondary outcomes:
measure: Target Lesion Failure
timeFrame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
measure: Any myocardial ischemia (MI)
timeFrame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
measure: Any revascularization
timeFrame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
measure: Ischemia-driven TLR
timeFrame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
measure: Probable and definite stent thrombosis defined by Academic Research Consortium (ARC)
timeFrame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
measure: Late lumen loss in segment
timeFrame: 9 months
measure: In-stent and in-segment binary restenosis rate
timeFrame: 9 months
measure: Device success
timeFrame: 0 day
measure: Procedure success
timeFrame: During the hospital stay to a maximum of the first seven days post index procedure
measure: Target lesion success
timeFrame: 0 day
measure: TLR
timeFrame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
measure: target vessel revascularization (TVR)
timeFrame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
measure: Patient oriented composite endpoint (PoCE)
timeFrame: 30days, 6 months, 9months, 12 months and yearly thereafter until 5 years
measure: In-stent and in-segment %diameter stenosis (%DS)
timeFrame: 9 months
measure: In-stent and in-segment minimum lumen diameter
timeFrame: 9 months
Other outcomes:
Locations:
city: Meizhou
country: China
facility: Meizhou Peple's Hospital
state: Guangdong
Study officials:
affiliation: Meizhou Peple's Hospital in Guangdong Province
name: Zhi Xiong Zhong, MD
role: PRINCIPAL_INVESTIGATOR
References: