TARGET-PREMIER Trail in Evaluating the Safety and Efficacy of the Rapamycin Target Eluting Stent in CAS Treatment

NCT04951050 | Active Not Recruiting

• 1 other identifier: D-IC-035
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Coronary Stenosis

Outcome Measures

Primary Outcomes (1)

• In-stent late loss

  In-stent late loss at 9 months post-procedure as measured by quantitative coronary angiography (QCA)

  9 months

Secondary Outcomes (15)

• Target Lesion Failure

  30days, 6 months, 9months, 12 months and yearly thereafter until 5 years

• Any myocardial ischemia (MI)

  30days, 6 months, 9months, 12 months and yearly thereafter until 5 years

• Any revascularization

  30days, 6 months, 9months, 12 months and yearly thereafter until 5 years

• 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)

  30days, 6 months, 9months, 12 months and yearly thereafter until 5 years

Study Arms (1)

Drug eluting stent

EXPERIMENTAL

Device: Rapamycin target eluting stent

Interventions

Rapamycin target eluting stent DEVICE

Rapamycin target eluting stent

Drug eluting stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test with on week before treatment.)

Sponsors & Collaborators

• Shanghai MicroPort Medical (Group) Co., Ltd.: lead

Study Sites (1)

Meizhou Peple's Hospital

Meizhou, Guangdong, 514000, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Zhi Xiong Zhong, MD

  Meizhou Peple's Hospital in Guangdong Province

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: July 6, 2021
• Study Start: February 28, 2022
• Primary Completion: August 26, 2023
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)