Safety and Efficacy of "Standardized" CHIP

Coronary Artery Disease Clinical Trial

Official title:

Safety and Efficacy of "Standardized" Complex High-risk Interventional Procedures - a New Pathway for Protected Percutaneous Coronary Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212378
• Other study ID #: FA_2017_01
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 30, 2020

Study information

• Verified date: November 2023
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 30, 2020
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Other:
• percutaneous coronary interventions
Percutaneous coronary intervention.

Locations

Country	Name	City	State
Germany	University Hospital Essen	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety & feasibility	Accurate classification of patients into the respective group defined by the necessity of upgrade	30 days
Primary	Hemodynamic Compromise (HC)	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	30 days.
Secondary	Major Adverse Cardiac and Cerebrovascular Events (MACCE)	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.	30 days
Secondary	Adverse events	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.	30 days