Safety and Efficacy of "Standardized" CHIP

NCT03212378 | Completed

• 1 other identifier: FA_2017_01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Safety & feasibility

  Accurate classification of patients into the respective group defined by the necessity of upgrade

  30 days

• 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 Outcomes (2)

• Major Adverse Cardiac and Cerebrovascular Events (MACCE)

  30 days

• Adverse events

  30 days

Study Arms (3)

CHIP 1 - low risk patients

Other: percutaneous coronary interventions

CHIP 2 - medium risk patients

Other: percutaneous coronary interventions

CHIP 3 - high risk patients

Other: percutaneous coronary interventions

Interventions

percutaneous coronary interventions OTHER

Percutaneous coronary intervention.

CHIP 1 - low risk patients; CHIP 2 - medium risk patients; CHIP 3 - high risk patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of consecutive high-risk subjects indicated for percutaneous complex high-risk interventional procedures.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45122, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 11, 2017
• Study Start: January 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 30, 2020
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

DE (1)