A Study to Evaluate the Impact of 11-month Ticagrelor Monotherapy Following One-month DAPT After PCI

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05015699
• Other study ID #: PIONEER IV CHINA
• Status: Withdrawn
• Phase: N/A
• Start date: September 2021
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Sino Medical Sciences Technology Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2025
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• HT Supreme
HT Supreme ( R&D by Sinomed, Tianjin, China)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sino Medical Sciences Technology Inc.	The Second Affiliated Hospital of Harbin Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The percentage of the struts' neointimal coverage (%) measured by OCT	80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT examination was carried out at 1 month after the operation to evaluate percentage of the struts' neointimal coverage	1 month post procedure
Other	Neointimal hyperplasia area/volume measured by OCT	80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT measures Neointimal hyperplasia area(mm2)/volume(mm3)	1 month post procedure
Other	Mean/Minimal Stent diameter/area/volume	80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT measures Mean/Minimal Stent diameter(mm)/area(mm2)/volume(mm3)	1 month post procedure
Other	Mean/maximal thickness of the struts coverage(%)	80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT measures Mean/maximal thickness of the struts coverage	1 month post procedure
Other	Mean/Minimal Lumen diameter/area/volume	80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT measures Mean/Minimal Lumen diameter(mm)/area(mm2)/volume(mm3)	1 month post procedure
Other	Incomplete strut apposition(%)	80 patients enrolled with an extra one-month OCT follow-up as a subgroup analysis target. OCT examination was carried out at 1 month after the operation to evaluate incomplete strut apposition	1 month post procedure
Primary	Rate of Patient-oriented Composite Endpoint (PoCE) at 12 months post-procedure.	PoCE is a composite clinical endpoint of: all-cause death; any stroke, Modified Rankin scale, (MRS =1); any myocardial infarction (peri-procedural MI according to SCAI, spontaneous according to 4th universal definition); any clinically and physiologically driven revascularization (ARC-2)	12 months post-procedure
Secondary	Rate of Patient oriented composite endpoint (PoCE) at 2 and 3 years;	PoCE is a composite clinical endpoint of: all-cause death; any stroke, Modified Rankin scale, (MRS =1); any myocardial infarction (periprocedural MI according to SCAI, spontaneous according to 4th universal definition); any clinically and physiologically driven revascularization (ARC-2)	2 and 3 years post-procedure
Secondary	Rate of Individual components of patient-oriented composite endpoint;	PoCE is a composite clinical endpoint of: all-cause death; any stroke, Modified Rankin scale, (MRS =1); any myocardial infarction (periprocedural MI according to SCAI, spontaneous according to 4th universal definition); any clinically and physiologically driven revascularization (ARC-2)	1, 2 and 3 years post-procedure
Secondary	Rate of Vessel-oriented composite endpoints (VoCE)	VoCE is a composite clinical endpoint of: Vessel-related cardiovascular Death; Target-vessel related MI; Clinically and physiologically-oriented Target vessel revascularization (ARC-2)	1, 2 and 3 years post-procedure
Secondary	Rate of Individual components of vessel-oriented composite endpoint;	VoCE is a composite clinical endpoint of: Vessel-related cardiovascular Death; Target-vessel related MI; Clinically and physiologically-oriented Target vessel revascularization (ARC-2)	1, 2 and 3 years post-procedure
Secondary	Rate of Device-oriented composite endpoint (DoCE) at all timepoints;	VoCE is a composite clinical endpoint of: Cardiovascular Death;Target-vessel related MI;Clinically and physiologically-oriented Target lesion revascularization	30days, 6months, annually up to 3 years post procedure
Secondary	Rate of Individual components of device-oriented composite endpoint;	VoCE is a composite clinical endpoint of: Cardiovascular Death;Target-vessel related MI;Clinically and physiologically-oriented Target lesion revascularization	30days, 6months, annually up to 3 years post procedure
Secondary	Rate of Pre-procedural myocardioal infarction according to 4th universal definition;	Fourth Universal Definition of Myocardial Infarction (2018)	30days, 6months, annually up to 3 years post procedure
Secondary	Device Success Rate	according to the statement from European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology (ESC))	intra-operative
Secondary	Rate of Stent thrombosis	Stent thrombosis is consist of Definite stent thrombosis; Probable stent thrombosis; Definite or probable stent thrombosis	30days, 6months, annually up to 3 years post procedure
Secondary	Rate of Target-vessel failure composite endpoint	TVF is a composite clinical endpoint of: Cardiac death; Myocardial Infarction (MI) (unless clearly attributable to a non target vessel); Target vessel revascularization	30days, 6months, annually up to 3 years post procedure
Secondary	Rate of Individual components of Target-vessel failure composite endpoint	TVF is a composite clinical endpoint of: Cardiac death; Myocardial Infarction (MI) (unless clearly attributable to a non target vessel); Target vessel revascularization	30days, 6months, annually up to 3 years post procedure
Secondary	Rate of Bleeding according to BARC (2, 3 and 5) classification	Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk	30days, 6months, annually up to 3 years post procedure
Secondary	Rate of Net adverse clinical and cerebral events	NACCE is a composite clinical endpoint of: any cause, myocardial infarction (MI), cerebral vascular accident, and major bleeding (according to the modified REPLACE-2 and GUSTO criteria)	30days, 6months, annually up to 3 years post procedure
Secondary	Cost-Effectiveness	Cost of procedure will be collected in the eCRF(e.g. diagnostic tests, procedural materials, time of the procedure, re-angiography, repeat revascularization, etc. will be quantified).	hospitalization, 1 year post procedure