Clinical trial NCT05015699: A Study to Evaluate the Impact of 11-month Ticagrelor Monotherapy Following One-month DAPT After PCI
Official title: A Prospective, Multi-center, Single-group Target Value Post-marketing Clinical Study to Evaluate the Safety and Effectiveness of the HT Supreme Drug-eluting Stent System in the Treatment of "Real-world" Patients With Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Healing-Targeted Supreme
one month DAPT
Lead sponsor: Sino Medical Sciences Technology Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Second Affiliated Hospital of Harbin Medical University
First posted: 2021-08-20
Enrollment: 0
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: PIONEER IV CHINA is sought to investigate the safety and efficacy of 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) after HT Supreme drug-eluting stent system at 12 months follow-up.

Detailed description: This study is a prospective, multi-center, single-arm objective performance criteria clinical trial in an all-comers patient population (including patients with high bleeding risk, HBR) undergoing PCI with unrestrictive use of the HT Supreme sirolimus-eluting stent and treated with 11-month ticagrelor monotherapy following one-month dual antiplatelet therapy (DAPT) in approximately 285 patients (including 80 coronary heart disease cases entering the OCT subgroup). All patients will be (at minimum) contacted via visit at 30 days (±7 days) and at 12 months (±30 days), and by phone contact at 6 months (±14 days), 24 months (±30 days) and 36 months (±45 days) post index procedure to assess clinical status and adverse events. The Primary Endpoint for this trial is Patient-oriented Composite Endpoint (PoCE) at 12 months post-procedure.

Eligibility criteria: Inclusion Criteria:

1. Male or female patient ≥18 years of age;
2. Patient has chronic stable angina, acute coronary syndromes or silent ischemia;
3. Presence of one or more coronary artery stenoses of ≥50% (by visual assessment) in a native coronary artery (with or without prior stent/other device treatment) or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation;
4. The vessel should have a reference vessel diameter of at least 2.25 mm by visual assessment (no limitation on the number of treated lesions, vessels, or lesion length);
5. Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee and is willing to comply with all protocol-required (follow-up) evaluations.

Exclusion Criteria:

1. under 18 years of age;
2. Unable to sign written informed consent
3. Patient is a woman who is pregnant or nursing
4. Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors;
5. Planned major elective surgery requiring discontinuation of DAPT within 12 months of procedure;
6. Concurrent medical condition with a life expectancy of less than 3 years;
7. Currently participating in another trial and not yet at its primary endpoint
8. Active pathological bleeding;
9. History of intracranial haemorrhage.

OCT exclusion criteria

1. Left main lesion
2. Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter
3. Total occlusion or thrombolysis in myocardial infarction(TIMI) flow 0, prior to wire crossing.

Primary outcomes:
measure: Rate of Patient-oriented Composite Endpoint (PoCE) at 12 months post-procedure.
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Rate of Patient oriented composite endpoint (PoCE) at 2 and 3 years;
timeFrame: 2 and 3 years post-procedure
measure: Rate of Individual components of patient-oriented composite endpoint;
timeFrame: 1, 2 and 3 years post-procedure
measure: Rate of Vessel-oriented composite endpoints (VoCE)
timeFrame: 1, 2 and 3 years post-procedure
measure: Rate of Individual components of vessel-oriented composite endpoint;
timeFrame: 1, 2 and 3 years post-procedure
measure: Rate of Device-oriented composite endpoint (DoCE) at all timepoints;
timeFrame: 30days, 6months, annually up to 3 years post procedure
measure: Rate of Individual components of device-oriented composite endpoint;
timeFrame: 30days, 6months, annually up to 3 years post procedure
measure: Rate of Pre-procedural myocardioal infarction according to 4th universal definition;
timeFrame: 30days, 6months, annually up to 3 years post procedure
measure: Device Success Rate
timeFrame: intra-operative
measure: Rate of Stent thrombosis
timeFrame: 30days, 6months, annually up to 3 years post procedure
measure: Rate of Target-vessel failure composite endpoint
timeFrame: 30days, 6months, annually up to 3 years post procedure
measure: Rate of Individual components of Target-vessel failure composite endpoint
timeFrame: 30days, 6months, annually up to 3 years post procedure
measure: Rate of Bleeding according to BARC (2, 3 and 5) classification
timeFrame: 30days, 6months, annually up to 3 years post procedure
measure: Rate of Net adverse clinical and cerebral events
timeFrame: 30days, 6months, annually up to 3 years post procedure
measure: Cost-Effectiveness
timeFrame: hospitalization, 1 year post procedure
Other outcomes:
measure: The percentage of the struts' neointimal coverage (%) measured by OCT
timeFrame: 1 month post procedure
measure: Neointimal hyperplasia area/volume measured by OCT
timeFrame: 1 month post procedure
measure: Mean/Minimal Stent diameter/area/volume
timeFrame: 1 month post procedure
measure: Mean/maximal thickness of the struts coverage(%)
timeFrame: 1 month post procedure
measure: Mean/Minimal Lumen diameter/area/volume
timeFrame: 1 month post procedure
measure: Incomplete strut apposition（%）
timeFrame: 1 month post procedure
Locations:
Study officials:
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: Bo Yu, PH.D
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: Haibo Jia, PH.D
role: STUDY_DIRECTOR
References: