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e- Ultimaster: Prospective, Single-Arm, Multi-Centre, Observational Registry on Ultimaster DES System

e- Ultimaster: Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Ultimaster DES System in Unselected Patients Representing Everyday Clinical Practice - e-Ultimaster

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2016/08/007213
Enrollment
760
Registered
2016-08-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery Health Condition 2: null- Coronary Artery Disease

Interventions

None listed

Sponsors

Terumo India Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: .Patient is above or equal to 18 years old .Patient is eligible for percutaneous coronary intervention using DES as per hospital routine .Patient agrees to provide written informed consent as approved by IRB or IEC

Exclusion criteria

Exclusion criteria: .The patients with lesion characteristics not suitable for the treatment with Ultimaster DES will not be enrolled .Patient not willing to provide written informed consent

Design outcomes

Primary

MeasureTime frame
Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 yearTimepoint: 1 year post index procedure

Secondary

MeasureTime frame
Success endpoints .Procedural Success .Device Success Safety endpoints .Cardiac Death/MI (peri & post procedural) .Stent Thrombosis .Major Vascular & bleeding complications Efficacy and patient oriented (composite) endpoints .Target Lesion Revascularization Rate .Target Vessel Failure Rate .Patient Oriented Composite Endpoint defined as any cause of mortality, MI or any TVRTimepoint: At 3 months and 1 year post index procedure

Countries

India

Contacts

Public ContactDr Sandeep Arora
Sandeep_Arora@terumo.co.jp

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026