NCT04582877Completed
Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial
Source: ClinicalTrials.gov · Last updated 2 Dec 2024
Brief summary (registry, in English)
Patients 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 300 (actual)
- First submitted
- 17 Sept 2020
- Start date
- 23 Sept 2020
- Primary completion date
- 15 Nov 2023
- Lead sponsor
- Zurich Medical Inc.
- NCT number
- NCT04582877
What you commit to
- Study type: Interventional
- Participants enrolled: 300
- From 23 Sept 2020 to the primary completion date, 15 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Coronary intervention surgery contraindications;
Other illness
- Has a history of myocardial infarction;
- 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;
- Left main coronary artery disease, target blood vessels with severe curvature or calcification lesions, total occlusion;
Lab values
- 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;
Other
- Patient who do not understand or are unwilling to sign an informed consent form;
- The angiography shown or suspect of dissection;
- There are any other factors that the investigator considers unsuitable for inclusion or completion of this study.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.