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

Primary Purpose

Myocardial Ischemia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
FFR measurement
Sponsored by
Zurich Medical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Ischemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FFR Measurement in Intermediate-Grade Coronary Stenosis

Arm Description

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).

Outcomes

Primary Outcome Measures

Compared FFR Measurement Between Test Article and Predicate Article

Secondary Outcome Measures

Full Information

First Posted
September 17, 2020
Last Updated
October 7, 2020
Sponsor
Zurich Medical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04582877
Brief Title
Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial
Official Title
Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 23, 2020 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zurich Medical Inc.

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FFR Measurement in Intermediate-Grade Coronary Stenosis
Arm Type
Other
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
FFR measurement
Intervention Description
FFR is measured sequentially with the test article and the predicate device.
Primary Outcome Measure Information:
Title
Compared FFR Measurement Between Test Article and Predicate Article
Time Frame
Acute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Chan
Phone
651-571-0020
Ext
103
Email
cchan@zurichmed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amber Daly
Phone
651-571-0020
Ext
118
Email
adaly@zurichmed.com
Facility Information:
Facility Name
Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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