CUSTOM III Trial (Xtent Custom NX 60 Drug Eluting Stent (ES) Catheter System Trial

CUSTOM III Trial (Xtent Custom NX 60 Drug Eluting Stent (ES) Catheter System Trial - CUSTOM III Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30652

Enrollment

Registered

2007-05-22

Start date

2007-06-19

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

atherosclerose coronary artery sclerosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - at least 18 years - acceptable candidate for PTCA - clinical evidence of ischemic heart disease - target lesion are de novo and stenosis >50% and 2,25 mm and

Exclusion criteria

Exclusion criteria: - left ventricular ejection fraction

Design outcomes

Primary

Measure	Time frame
Primary Endpoint: The rate of Major Adverse Cardiac Event (MACE) at 30 days (1 month).	—

Secondary

Measure	Time frame
Secondary Endpoints: Include MACE rate at 6 months, the incidence of bleeding and/or vascular complications, the incidence of (sub)acute stent thrombosis (SAT) at discharge, 30 days (1 month) and 6 months. In addition: angiographic endpoints, device performance endpoints and other safety endpoints.	—

Countries

Netherlands

Outcome results