Safety and Efficacy of "Standardized" CHIP

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: percutaneous coronary interventions

• Registration Number: NCT03212378
• Lead Sponsor: University Hospital, Essen

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-06
• Study First Posted: 2017-07-11
• Primary Completion: 2017-12-31
• Study Completion: 2020-12-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CHIP 2 - medium risk patients	percutaneous coronary interventions	-
CHIP 3 - high risk patients	percutaneous coronary interventions	-
CHIP 1 - low risk patients	percutaneous coronary interventions	-

Primary Outcome Measures

Name	Time	Method
Hemodynamic Compromise (HC)	30 days.	Freedom from hemodynamic compromise during PCI procedure defined as: mean arterial pressure (MAP) not decreasing to values below 60 mmHg for more than 10 minutes during the PCI procedure
Safety & feasibility	30 days	Accurate classification of patients into the respective group defined by the necessity of upgrade

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac and Cerebrovascular Events (MACCE)	30 days	A composite rate of the following intra-procedural and post-procedural Major Adverse Cardiac and Cerebrovascular Events (MACCE) events defined as death, new myocardial infarction, or cerebrovascular accident up to 30 days post index procedure.
Adverse events	30 days	Rates of acute kidney injury (\[AKI\] according to KDIGO), sepsis, vascular complications (defined by Valve Academic Research Consortium 2 \[VARC 2\]), bleeding (defined by Bleeding Academic Research Consortium \[BARC\]) and coronary complications.

Trial Locations

Locations (1)

University Hospital Essen; 🇩🇪 Essen, NRW, Germany