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OpenTrials
Completed

NCT Number: NCT03212378

Safety and Efficacy of "Standardized" CHIP

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Essen

Essen, North Rhine-Westphalia, 45122, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

percutaneous coronary interventions

Other

Percutaneous coronary intervention.

Primary outcomes

  1. Safety & feasibility

    Time frame: 30 days

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

  2. Hemodynamic Compromise (HC)

    Time frame: 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

Secondary outcomes

  1. Major Adverse Cardiac and Cerebrovascular Events (MACCE)

    Time frame: 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.

  2. Adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2020
First posted
Jul 11, 2017
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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