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Safety and Efficacy of "Standardized" CHIP

NCT ID: NCT03212378

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2020-12-30

Brief Summary

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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

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CHIP 1 - low risk patients

percutaneous coronary interventions

Intervention Type OTHER

Percutaneous coronary intervention.

CHIP 2 - medium risk patients

percutaneous coronary interventions

Intervention Type OTHER

Percutaneous coronary intervention.

CHIP 3 - high risk patients

percutaneous coronary interventions

Intervention Type OTHER

Percutaneous coronary intervention.

Interventions

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percutaneous coronary interventions

Percutaneous coronary intervention.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Essen

OTHER

Sponsor Role lead

Responsible Party

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Fadi Al-Rashid

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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FA_2017_01

Identifier Type: -

Identifier Source: org_study_id