Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
2500 participants
INTERVENTIONAL
2022-09-22
2030-06-30
Brief Summary
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Insightful-FFR is an investigator-driven, multicenter, randomized, open-label and prospective trial of patients with stable coronary artery disease or stabilised non-ST elevation acute coronary syndrome (ACS) with epicardial stenosis considered for PCI aiming at comparing clinical outcomes between pressure microcatheter and pressure wire-guided strategies. The study hypothesis states that the use of a Pressure Microcatheter for clinical decision making would be non-inferior to pressure wire-based strategy
After determining the presence of a coronary artery disease/ stabilized acute coronary syndrome, patients will be randomized to use a pressure microcatheter (investigational device) or a pressure wire (comparator) to guide and optimize percutaneous coronary intervention (PCI). Patients will be followed up in hospital at 12 months and yearly until five years.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
The one-step randomization process in four groups permits an uninterrupted invasive procedure avoiding the logistic issues related to a second randomization during the invasive procedure while preserving the statistical power and balance between groups.
TREATMENT
NONE
Study Groups
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Pressure Microcatheter guided strategy - PIOS-MC
Patients will be treated with the Pressure Microcatheter during PCI. After completing an angiographically successful PCI, patients will be randomized to FFR-guided stent optimization (PIOS).
Pressure Microcatheter guided strategy - PIOS MC
Use of Pressure Microcatheter during PCI. After the PCI, the patient will receive treatment according to the incremental optimization strategy (PIOS) .
Pressure Wire guided strategy - PIOS-PW
Patients will be treated with the Pressure Wire during PCI. After completing an angiographically successful PCI, patients will be randomized to FFR-guided stent optimization (PIOS).
Pressure Wire guided strategy - PIOS - PW
Use of Pressure Wire during PCI. After the PCI, the patient will receive treatment according to the incremental optimization strategy (PIOS) .
Pressure Microcatheter guided strategy - Standard of care
Patients will be treated with the Pressure Microcatheter during PCI. After completing an angiographically successful PCI, patients will receive the standard of care treatment.
Pressure Microcatheter guided strategy - Standard of care
Use of Pressure Microcatheter during PCI. After the PCI, the patient will receive standard of care treatment.
Pressure Wire guided strategy - Standard of care
Patients will be treated with the Pressure Wire during PCI. After completing an angiographically successful PCI, patients will receive the standard of care treatment.
Pressure Wire guided strategy - Standard of care
Use of Pressure Wire during PCI. After the PCI, the patient will receive standard of care treatment.
Interventions
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Pressure Microcatheter guided strategy - PIOS MC
Use of Pressure Microcatheter during PCI. After the PCI, the patient will receive treatment according to the incremental optimization strategy (PIOS) .
Pressure Wire guided strategy - PIOS - PW
Use of Pressure Wire during PCI. After the PCI, the patient will receive treatment according to the incremental optimization strategy (PIOS) .
Pressure Microcatheter guided strategy - Standard of care
Use of Pressure Microcatheter during PCI. After the PCI, the patient will receive standard of care treatment.
Pressure Wire guided strategy - Standard of care
Use of Pressure Wire during PCI. After the PCI, the patient will receive standard of care treatment.
Eligibility Criteria
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Inclusion Criteria
2. Eligible for elective PCI.
3. Stable angina or ACS (non-culprit vessels only and outside of primary intervention during acute STEMI)
4. Subject willing to participate and able to understand, read and sign the Informed Consent.
Exclusion Criteria
2. Chronic total occlusion as a target vessel.
3. Significant contraindication to adenosine administration (e.g. heart block, severe asthma)
4. Uncontrolled or recurrent ventricular tachycardia.
5. Hemodynamic instability.
6. Severe valvular disease.
7. Severe renal dysfunction defined as an eGFR ≤30 mL/min/1.73 m2.
8. Comorbidity with life expectancy ≤ 2 years.
9. Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12 months in the patient presenting with an ACS, or at least six months in the patient presenting with stable CAD, unless the patient is also taking chronic oral anticoagulation in which case a shorter duration of DAPT may be prescribed per local standard of care.
10. Planned major cardiac or non-cardiac surgery within 24 months after the index procedure. Note: major surgery is any invasive procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. Note: minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded.
11. Subject has known hypersensitivity or contraindication to any of the study drugs (including all P2Y12 inhibitors, one or more components of the study devices, including everolimus, zotarolimus, biolimus, sirolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoropolymers, or radiocontrast dye that cannot be adequately pre- medicated.
12. The subject has received a functioning solid organ transplant or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.
13. The subject receives immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
14. The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum.
15. Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3.
16. The subject has a documented or suspected hepatic disorder defined as cirrhosis or Child-Pugh ≥ Class B.
17. The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, any prior intracranial bleed, any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy of \<2 years for any non-cardiac cause.
18. The subject is currently participating in another investigational drug or device clinical study.
19. Pregnancy or nursing.
20. Presence of other anatomic or comorbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements or impact the scientific soundness of the clinical investigation results.
18 Years
85 Years
ALL
No
Sponsors
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Insight Lifetech Co., Ltd.
INDUSTRY
CoreAalst BV
INDUSTRY
Responsible Party
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Principal Investigators
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Emanuele Barbato, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Universitaria Sant'Andrea, Roma
Carlos Collet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CoreAalst BV
Junbo Ge, MD
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Hospital, Fudan University, Shanghai
Salvatore Brugaletta, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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OLV Aalst
Aalst, Oost-Vlaanderen, Belgium
Universitair ziekenhuis Brussel
Brussels, , Belgium
ZOL
Genk, , Belgium
Zhongshan Hospital of Fudan University
Shanghai, Xuhui District, China
QILU Hospital of Shandong University
Shandong, , China
West China Hospital of Sichuan University
Sichuan, , China
CHU Lille
Lille, , France
Claude Bernard University
Lyon, , France
ICPS
Paris, , France
Herzzentrum Dresden
Dresden, , Germany
Klinikum Fürth
Fürth, , Germany
Klinikum Herford
Herford, , Germany
Catholic Medical Center Koblenz-Montabaur
Koblenz, , Germany
Herzzentrum Lahr
Lahr, , Germany
Universitätsklinik
Mainz, , Germany
Nuovo Arcispedale S.Anna Di Ferrara
Ferrara, , Italy
Ospedale Civile Sant'Andrea
La Spezia, , Italy
Ospedale Santa Maria Goretti
Latina, , Italy
Azienda Ospedaliera Universitaria Federico II
Naples, , Italy
Azienda Ospedaliera Universitaria Sant'Andrea
Rome, , Italy
Amsterdam UMC
Amsterdam, , Netherlands
Catharina Ziekenhuis
Eindhoven, , Netherlands
UMCN Radboud
Nijmegen, , Netherlands
Dr. Jurasz University Hospital No. 1
Bydgoszcz, , Poland
John Paul II Specialistic Hospital
Krakow, , Poland
National Cardiac Institute
Warsaw, , Poland
Hospital Clínic Barcelona
Barcelona, , Spain
Germans Trias i Pujol Hopital
Barcelona, , Spain
Hospital de Belvitge
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Marnix von Kemp, Md
Role: primary
Daan Cottens, MD
Role: primary
Eric Van Belle, MD
Role: primary
Nicolas Amabile, MD
Role: primary
Felix Woitek, MD
Role: primary
Stylianos Pyxaras, MD,PhD
Role: primary
Dominik Gorski, MD
Role: primary
Kambis Mashayekhi, MD, PhD
Role: primary
Tommaso Gori, MD, PhD
Role: primary
Gianluca Campo, MD
Role: primary
Marco Arena, MD
Role: primary
Iginio Colaiori, MD
Role: primary
Giovanni Esposito, MD
Role: primary
Emanuele Barbato, MD
Role: primary
Marcel Beijk, MD
Role: primary
Pim Tonino, MD
Role: primary
Lokien Van Nunen, MD
Role: primary
Adam Sukiennik, MD
Role: primary
Jacek Legutko, MD
Role: primary
Adam Witkowski, MD, PhD
Role: primary
Salvatore Brugaletta, MD, PhD
Role: primary
Oriol Rodriguez, MD
Role: primary
Josep Gomez Lara, MD
Role: primary
References
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Stalikas N, Mizukami T, Bouisset F, Ikeda K, Tajima A, Munhoz D, Mahendiran T, Wilgenhof A, Sakai K, Noorgard B, Engstroem T, Leipsic J, Stefanini G, Bartorelli A, Fairbairn T, Bagnall A, Ko B, Johnson NP, Berry C, Perera D, Christiansen EH, Shinke T, Otake H, Koo BK, Barbato E, Brugaletta S, Collison D, Campo G, Van Belle E, Goori T, Van Nunen L, Witkowski A, Astudillo P, Spratt J, Amano T, Ando H, Sianos G, Sonck J, Andreini D, De Bruyne B, Collet C. Vessel-Specific Myocardial Mass in Patients With Stable Coronary Artery Disease. J Am Heart Assoc. 2025 Nov 18;14(22):e039013. doi: 10.1161/JAHA.124.039013. Epub 2025 Nov 6.
Other Identifiers
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CA-053
Identifier Type: -
Identifier Source: org_study_id
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