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Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial

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ClinicalTrials.gov Identifier: NCT04582877
Recruitment Status : Recruiting
First Posted : October 12, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Zurich Medical Inc.

Study Description
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Brief Summary:
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System). Both articles are used within the same participant and the FFR values are statistically compared with each other.

Condition or disease Intervention/treatment Phase
Myocardial Ischemia Device: FFR measurement Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
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Arm Intervention/treatment
FFR Measurement in Intermediate-Grade Coronary Stenosis
Participants with intermediate-grade coronary stenosis undergo measurement of fractional flow reserve using the test article (Zurich Pressure Guidewire System) and predicate article (Abbott PressureWire System).
 Device: FFR measurement
FFR is measured sequentially with the test article and the predicate device.


Outcome Measures
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Primary Outcome Measures :
  1. Compared FFR Measurement Between Test Article and Predicate Article [ Time Frame: Acute ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 75 years old, gender-unrestricted, non-pregnant female;
  • Understand and be willing to sign an informed consent form;
  • Diagnosed with coronary heart disease;
  • Intrusive ICA and FFR measurement are needed;
  • Visual coronary angiography showed at least one moderate stenosis lesion (diameter stenosis of 30% - 70%) on the coronary artery with diameter ≥ 2.5mm

Exclusion Criteria:

  • Patient who do not understand or are unwilling to sign an informed consent form;
  • Has a history of myocardial infarction;
  • Patient with other serious diseases are not suitable for clinical trials, such as a complex congenital heart disease history, severe heart failure(NYHA cardiac function level IV), long QT syndrome, severe hypertension, Severe asthma, severe chronic obstructive pulmonary disease, liver and kidney dysfunction and other serious infections and critical illnesses;
  • Coronary intervention surgery contraindications;
  • Patient with ATP contraindications (ATP contraindications: sinus syndrome, sinus insufficiency and the elderly with cautious use or no use);
  • The clinical manifestations of patients show acute instability, including acute chest pain (sudden appearance), cardiogenic shock, unstable blood pressure (systolic pressure less than 90mmHg), severe congestive heart failure or acute pulmonary edema;
  • The angiography shown or suspect of thrombosis;
  • The angiography shown or suspect of dissection;
  • Left main coronary artery disease, target blood vessels with severe curvature or calcification lesions, total occlusion;
  • There are any other factors that the investigator considers unsuitable for inclusion or completion of this study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582877


Contacts
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Contact: Charles Chan 651-571-0020 ext 103 cchan@zurichmed.com
Contact: Amber Daly 651-571-0020 ext 118 adaly@zurichmed.com

Locations
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China, Shanghai
Zhongshan Hospital Recruiting
Shanghai, Shanghai, China
Sponsors and Collaborators
Zurich Medical Inc.
  Study Documents (Full-Text)

Documents provided by Zurich Medical Inc.:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] October 7, 2020

More Information
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Responsible Party: Zurich Medical Inc.
ClinicalTrials.gov Identifier: NCT04582877    
Other Study ID Numbers: WXYL-LC-2018001
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Myocardial Ischemia
Ischemia
Pathologic Processes
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases