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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.
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,
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional Flow Reserve | Device | Measurement of physiologic parameters |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Subjects Who Had a Change in Treatment Plan When FFR is Used Compared to the Initial Decision Based on Angiography Alone |
Inclusion Criteria:
Exclusion Criteria:
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Patients where FFR has been performed or is planned to be performed for further evaluation of PCI procedures, as per physician clinical practice.
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| Name | Affiliation | Role |
|---|---|---|
| Colin Berry, MD | University of Glasgow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research, LLC | Huntsville | Alabama | 35801 | United States | ||
| Orlando Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32170905 | Derived | Schampaert E, Kumar G, Achenbach S, Galli S, Tanaka N, Teraphongphom T, Ginn G, Zhang Z, Somi S, Amoroso G, Brueren G, Krasnow J, Knaapen P, Berry C; PRESSUREwire Investigators. A global registry of fractional flow reserve (FFR)-guided management during routine care: Study design, baseline characteristics and outcomes of invasive management. Catheter Cardiovasc Interv. 2020 Oct 1;96(4):E423-E431. doi: 10.1002/ccd.28827. Epub 2020 Mar 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | FFR-guided PCI Patients | Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS) who is undergoing Fractional flow reserve (FFR)-guided percutaneous intervention (PCI) procedure |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2016 |
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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 |
| 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 |
| 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 |
| 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 |
| Orlando |
| Florida |
| 32806 |
| United States |
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | United States |
| Providence Everett Medical Center | Everett | Washington | 98206 | United States |
| Allgemeines Krankenhaus Linz | Linz | 4020 | Austria |
| Krankenhaus Lainz | Vienna | Austria |
| London Health Sciences Centre | London | Canada |
| Hopital Sacre Coeur | Montreal | Canada |
| Aswan Cardiac Center | Aswān | Egypt |
| Al Dorrah Heart Care Hospital | Cairo | Egypt |
| North Estonia Medical Centre | Tallinn | Estonia |
| Tartu University Hospital | Tartu | Estonia |
| Universitätsklinikum Aachen | Aachen | Germany |
| St.-Johannes-Hospital | Dortmund | Germany |
| Medizinische Einrichtungen der Universität Düsseldorf | Düsseldorf | Germany |
| Kliniken der Friedrich-Alexander-Universitat | Erlangen | 91054 | Germany |
| Kliniken Villingen-Schwenningen | Villingen-Schwenningen | Germany |
| Alexandra General Hospital | Athens | Greece |
| University Hospital of Ioannina | Ioannina | Greece |
| 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 | India |
| Ospedale Maggiore-Bellaria | Bologna | Italy |
| Centro Cardiologico Monzino | Milan | 20138 | Italy |
| Policlinico di Modena | Modena | Italy |
| Azienda Ospedaliera Monaldi | Naples | Italy |
| Policlinico Universitario A. Gemelli | Roma | Italy |
| Ospedale di Trento - P.O.Santa Chiara | Trento | Italy |
| Gifu Heart Center | Gifu | Japan |
| Tokyo Medical University Hachioji Medical Center | Hachiōji | Japan |
| Kansai Rosai Hospital | Hyōgo | Japan |
| Tenyoukai Central Hospital | Kagoshima | Japan |
| Yokosuka Kyosai Hospital | Kanagawa | Japan |
| Kanazawa Cardiovascular Hospital | Kanazawa | Japan |
| Gunma Prefectural Cardiovascular Center | Maebashi | Japan |
| Nishinomiya Watanabe Cardiovascular Center | Nishinomiya-shi | Japan |
| Sapporo Cardiovascular Clinic | Sapporo | 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 | Japan |
| VU Amsterdam | Amsterdam | 1081HV | Netherlands |
| Onze Lieve Vrouw Gasthuis | Amsterdam | 1091 AC | Netherlands |
| Amphia Hospital | Breda | Netherlands |
| Catharina Ziekenhuis | Eindhoven | Netherlands |
| Haga Ziekenhuis Locatie Leyenburg | The Hague | 2545AA | Netherlands |
| Hospital Garcia de Orta, EPE | Almada | Portugal |
| Santa Maria Hospital | Lisbon | Portugal |
| Hospital do Divino Espírito Santo | Ponta Delgada | Portugal |
| Centro Hospitalar Vila Nova Gaia | Vila Nova de Gaia | Portugal |
| King Abdullah Medical City | Mecca | Saudi Arabia |
| King Khalid University Hospital | Riyadh | Saudi Arabia |
| Hospital de Basurto | Bilbao | 48013 | Spain |
| Hospital Asistencial Universitario de Burgos | Burgos | 09006 | Spain |
| Hospital Universitario Donostia | Donostia / San Sebastian | Spain |
| Complejo Hospitalario de Jaen | Jaén | 23007 | Spain |
| Hospital Universitario Son Espases | Palma de Mallorca | Spain |
| Complejo Hospital Nuestra Señora de la Candelaria | Santa Cruz de Tenerife | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Spain |
| 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 Kingdom |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FFR-guided PCI Patients | Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS) who are undergoing fractional flow reserve (FFR)-guided Percutaneous intervention (PCI) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | The denominators used in the calculations of adverse event rates will be determined according to the analysis population excluding subjects who are lost to follow-up through given time point without events. | Posted | Count of Participants | Participants | 12 months |
|
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Correlation of Resting Indices With FFR Values | Linear correlation will be used for continuous variables to examine agreement between FFR values and resting indices. | The number of participants and lesions analyzed were based on the number of participants underwent both FFR and Pd/Pa measurements for this Outcome Measure | Posted | Number | correlation coefficient | at time of procedure | Lesion | Lesion |
|
| |||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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". | Posted | Count of Participants | Participants | at time of procedure |
|
| ||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | The denominators used in the calculations of adverse event rates will be determined according to the analysis population excluding subjects who are lost to follow-up through given time point without events. | Posted | Count of Participants | Participants | 12 months |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | The denominators used in the calculations of adverse event rates will be determined according to the analysis population excluding subjects who are lost to follow-up through given time point without events. | Posted | Count of Participants | Participants | 12 months |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | The number of participants and lesions analyzed were based on the number of participants underwent both FFR and cFFR measurements for this Outcome Measure | Posted | Number | correlation coefficient | at time of procedure | Lesion | Lesion |
|
|
12 months
Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device under study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FFR-guided PCI Patients | Patients presented with either stable coronary artery disease (CAD) or acute coronary syndrome (ACS) | 50 | 2,217 | 107 | 2,217 | 114 | 2,217 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cardiac disorders | Cardiac disorders | Systematic Assessment | MI, Chest Pain, Heart Failure |
| |
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
| ||
| General disorders | General disorders | Systematic Assessment |
| ||
| Infections and infestations | Infections and infestations | Systematic Assessment |
| ||
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment | Dissection |
| |
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Nervous system disorders | Nervous system disorders | Non-systematic Assessment |
| ||
| Renal and urinary disorders | Renal and urinary disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Acute Aneurysm Abdominalis | Surgical and medical procedures | Systematic Assessment |
| ||
| Vascular disorders | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Cardiac disorders | Cardiac disorders | Systematic Assessment | MI, Chest Pain |
| |
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
| ||
| General disorders | General disorders | Systematic Assessment |
| ||
| Infections and infestations | Infections and infestations | Systematic Assessment |
| ||
| Dissection | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Nervous system disorders | Nervous system disorders | Systematic Assessment |
| ||
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Acute Aneurysm Abdominalis | Surgical and medical procedures | Systematic Assessment |
| ||
| Vascular disorders | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tarn Teraphongphom, Sr. Clinical Scientist | Abbott Vascular | 408-9310504 | tarn.teraphongphom@abbott.com |
| Jan 6, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Egypt |
|
| United Kingdom |
|
| Portugal |
|
| Spain |
|
| India |
|
| Greece |
|
| Saudi Arabia |
|
| Canada |
|
| Austria |
|
| Netherlands |
|
| Italy |
|
| Germany |
|
| Estonia |
|
| Myocardial infarction |
|
| Urgent revascularization |
|
| Lesion |
|
|
|
|
|
| Lesion |
|
|