Safety and Efficacy of "Standardized" CHIP

University Hospital Essen

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Other: percutaneous coronary interventions

Study type: Observational

Funder types: Other

Identifiers

NCT03212378

FA_2017_01

Details and patient eligibility

About

In routine clinical practice, high-risk patients with high-risk anatomies are more often referred for interventional treatment by percutaneous coronary interventions (PCI). Current guidelines only suggest that elective insertion of an appropriate hemodynamic support device as an adjunct to PCI may be reasonable in selected high-risk patients.

The objective of this study is to investigate the safety and efficacy of a "standardized program" for complex high-risk interventional procedures (CHIP).

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed Informed Consent
• Non emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft

Exclusion criteria

• Subject has uncorrectable abnormal coagulation parameters (defined as platelet count ≤75,000/mm3 or INR ≥2.5.)
• History of recent (within 1 month) stroke or TIA
• Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors

Trial design

150 participants in 3 patient groups

CHIP 1 - low risk patients

Treatment:

Other: percutaneous coronary interventions

CHIP 2 - medium risk patients

Treatment:

Other: percutaneous coronary interventions

CHIP 3 - high risk patients

Treatment:

Other: percutaneous coronary interventions