PRESSUREwire Study

Coronary Artery Disease Clinical Trial

Official title:

Practical Evaluation of Fractional Flow Reserve (FFR) and Its Associated Alternate Indices During Routine Clinical Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02935088
• Other study ID #: SJM-CIP-10136
• Status: Completed
• Start date: October 12, 2016
• Est. completion date: March 22, 2019

Study information

• Verified date: January 2020
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to understand routine use of FFR (Fractional Flow Reserve) and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures.

Description:

The purpose of this study is to understand routine use of FFR and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures.

The study will also collect data on the routine use of coronary physiologic measurements such as adenosine-induced hyperemia FFR, FFR by contrast-induced hyperemia,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2217
• Est. completion date: March 22, 2019
• Est. primary completion date: March 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is presenting with STEMI, NSTEMI, unstable angina, or stable coronary artery disease

• Patient is planned to have FFR performed or underwent a cardiac catheterization where FFR was performed for further PCI (Percutaneous Cardiac Intervention) consideration

• Patient signs and dates written informed consent

• Patient is eighteen years of age or older at the time of consent

Exclusion Criteria:

• Patient has extremely tortuous or calcified coronary arteries

• Patient with a patent coronary artery bypass graft to the target vessel

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease

Intervention

Device:
• Fractional Flow Reserve
Measurement of physiologic parameters

Locations

Country	Name	City	State
Austria	Allgemeines Krankenhaus Linz	Linz
Austria	Krankenhaus Lainz	Vienna
Canada	London Health Sciences Centre	London
Canada	Hopital Sacre Coeur	Montreal
Egypt	Aswan Cardiac Center	Aswan
Egypt	Al Dorrah Heart Care Hospital	Cairo
Estonia	North Estonia Medical Centre	Tallinn
Estonia	Tartu University Hospital	Tartu
Germany	Universitätsklinikum Aachen	Aachen
Germany	St.-Johannes-Hospital	Dortmund
Germany	Medizinische Einrichtungen der Universität Düsseldorf	Dusseldorf
Germany	Kliniken der Friedrich-Alexander-Universitat	Erlangen
Germany	Kliniken Villingen-Schwenningen	Villingen-Schwenningen
Greece	Alexandra General Hospital	Athens
Greece	University Hospital of Ioannina	Ioannina
India	Postgraduate Institute of Medical Education & Research	Chandigarh
India	Apollo Hospital	Chennai
India	The Madras Medical Mission	Chennai
India	Medanta - The Medicity Hospital	Gurgaon
India	Fortis Escorts Hospital, Jaipur	Jaipur
India	Lisie Hospital	Kochi
India	Caritas Hospital	Kottayam
India	Sunshine Hospitals	Secunderabad
India	Ananthapuri Hospitals and Research Institute	Thiruvananthapuram
India	Sree Chitra Tirunal Institute for Medical Sciences and tech.	Trivandrum
India	Christian Medical College & Hospital	Vellore
Italy	Ospedale Maggiore-Bellaria	Bologna
Italy	Centro Cardiologico Monzino	Milano
Italy	Policlinico di Modena	Modena
Italy	Azienda Ospedaliera Monaldi	Napoli
Italy	Policlinico Universitario A. Gemelli	Roma
Italy	Ospedale di Trento - P.O.Santa Chiara	Trento
Japan	Gifu Heart Center	Gifu-shi
Japan	Tokyo Medical University Hachioji Medical Center	Hachioji
Japan	Kansai Rosai Hospital	Hyogo
Japan	Tenyoukai Central Hospital	Kagoshima-shi
Japan	Yokosuka Kyosai Hospital	Kanagawa
Japan	Kanazawa Cardiovascular Hospital	Kanazawa
Japan	Gunma Prefectural Cardiovascular Center	Maebashi-shi
Japan	Nishinomiya Watanabe Cardiovascular Center	Nishinomiya-shi
Japan	Sapporo Cardiovascular Clinic	Sapporo-shi
Japan	Tohoku University Hospital	Sendai
Japan	Higashi Takarazuka Satoh Hospital	Takarazuka
Japan	Tsuchiura Kyodo General Hospital	Tsuchiura-shi
Japan	Yokohama City University Medical Center	Yokohama-shi
Netherlands	Onze Lieve Vrouw Gasthuis	Amsterdam
Netherlands	VU Amsterdam	Amsterdam
Netherlands	Amphia Hospital	Breda
Netherlands	Haga Ziekenhuis Locatie Leyenburg	Den Haag
Netherlands	Catharina Ziekenhuis	Eindhoven
Portugal	Hospital Garcia de Orta, EPE	Almada
Portugal	Santa Maria Hospital	Lisboa
Portugal	Hospital do Divino Espírito Santo	Ponta Delgada
Portugal	Centro Hospitalar Vila Nova Gaia	Vila Nova de Gaia
Saudi Arabia	King Abdullah Medical City	Mecca
Saudi Arabia	King Khalid University Hospital	Riyadh
Spain	Hospital de Basurto	Bilbao
Spain	Hospital Asistencial Universitario de Burgos	Burgos
Spain	Complejo Hospitalario de Jaen	Jaen
Spain	Hospital Universitario Son Espases	Palma de Mallorca
Spain	Hospital Universitario Donostia	San Sebastian
Spain	Complejo Hospital Nuestra Señora de la Candelaria	Santa Cruz De Tenerife
Spain	Hospital Universitario Marqués de Valdecilla	Santander
United Kingdom	Golden Jubilee National Hospital	Clydebank
United Kingdom	Kettering General Hospital	Kettering
United Kingdom	Royal Free Hospital	London
United Kingdom	St. Bartholomew's Hospital	London
United States	Atlanta VA Medical Center	Decatur	Georgia
United States	Providence Everett Medical Center	Everett	Washington
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	Orlando Health	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Egypt,  Estonia,  Germany,  Greece,  India,  Italy,  Japan,  Netherlands,  Portugal,  Saudi Arabia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation of Resting Indices With FFR Values	Linear correlation will be used for continuous variables to examine agreement between FFR values and resting indices.	at time of procedure
Other	Number of Subjects Who Had a Change in Treatment Plan When FFR is Used Compared to the Initial Decision Based on Angiography Alone	Treatment decision was defined as "changed" if there is at least one decision change based on FFR for multiple lesions; if none of the decisions was changed for the multiple lesions, the treatment decision is defined as "unchanged".	at time of procedure
Other	Number of Subjects With 12-Month Clinical Outcomes (MACE) Major Adverse Cardiac Events of Follow-up Subjects in Whom the Use of FFR Did Not Lead to a Change in Treatment Decision vs Subjects in Whom the Use of FFR Led to a Change in Treatment Decision	Number of subjects with 12-Month Clinical Outcomes (MACE) Major Adverse Cardiac Events of Follow-up subjects in whom the use of FFR did not lead to a change in treatment decision vs subjects in whom the use of FFR led to a change in treatment decision.	12 months
Other	Number of Subjects With 12-month Clinical Outcomes (MACE) by Other PressureWire-derived Indices (Contrast FFR)	Number of subjects with 12-month clinical outcomes (MACE) by other PressureWire-derived indices (contrast FFR).; Major adverse cardiac events (MACE) is defined as a 12-month composite, including all cause death, documented non-fatal myocardial infarction, and unplanned hospitalization leading to urgent revascularization.	12 months
Other	Correlation of Other PressureWire-derived Index, Contrast FFR With FFR Values	Linear correlation of FFR and contrast FFR (cFFR). Only subjects that had both FFR and cFFR were used in the analysis.	at time of procedure
Primary	Number of Subjects With 12 Month Clinical Outcomes (MACE) Major Adverse Cardiac Events by FFR Values and Resting Indices	Major adverse cardiac events (MACE) is defined as a 12-month composite, including all cause death, documented non-fatal myocardial infarction, and unplanned hospitalization leading to urgent revascularization.; Fisher Exact test will be performed to evaluate the association between 12-month MACE event and binary FFR variables respectively using the following FFR; Low FFR group (FFR = 0.8) and high FFR group (FFR > 0.8).	12 months