IRIS Ultimaster Cohort in the IRIS-DES Registry

Browse trials for

• Coronary Artery Disease 5,581

Keywords

• real world data
• percutaneous coronary intervention
• drug eluting stent

Study population

Groups and cohorts

• Ultimaster stent

  Device: Ultimaster stent

Interventions

• DeviceUltimaster stent

Primary outcomes

1. Composite event

   The number of events with the first occurrence of a composite event(death, non-fatal myocardial infarction, target vessel revascularization)

   Time frame: 1year

Secondary outcomes

1. All death

   Time frame: 5years

2. Cardiac death

   Time frame: 5years

3. Myocardial infarction

   Time frame: 5years

4. Composite event of death or myocardial infarction

   Time frame: 5years

5. Composite event of cardiac death or myocardial infarction

   Time frame: 5years

6. Target Vessel revascularization

   Defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself. Clinical-driven Clinically indicated angiography at follow-up shows a percent diameter stenosis ≥ 50% (core lab QCA assessment) and if one of the following occurs: (1) a positive history of recurrent angina pectoris, presumably related to the target vessel; (2) objective signs of ischemia at rest (ECG changes) of during exercise test (or equivalent), presumably related to the target vessel; (3) abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity reserve, fractional flow reserve). Ischemia-driven if one of followings of above-mentioned symptom (clinical-driven) or sign of ischemia or diameter stenosis ≥ 70 %

   Time frame: 5years

7. Target Lesion revascularization

   Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLRs should be classified prospectively as clinically indicated or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.

   Time frame: 5years

8. Stent thrombosis

   DEFINITE stent thrombosis : acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE stent thrombosis : unexplained death within 30 days or target-vessel infarction without angiographic information Academic Research Consortium (ARC) stent thrombosis is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute stent thrombosis: 0-24 hours after stent implantation; Subacute stent thrombosis: \>24 hours to 30 days post; late stent thrombosis: \>30 days to 1 year post; Very late stent thrombosis: \>1 year post;

   Time frame: 5years

9. Stroke

   Time frame: 5years

10. Procedural success

    Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death

    Time frame: 3days

Individual participant data

Plan to share: Undecided