🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT05437900
Recruiting Phase 4

INSIGHTFUL-FFR Clinical Trial

NCT05437900 · tracked via the Priya Life Science China tracker
Sponsor
CoreAalst BV
Phase
Phase 4
Started
2022-09-22
Last updated
2026-01-12

Condition(s) studied

Coronary Artery DiseaseAcute Coronary Syndrome

Investigational drug(s) / intervention(s)

Pressure Microcatheter guided strategy - PIOS MCPressure Wire guided strategy - PIOS - PWPressure Microcatheter guided strategy - Standard of carePressure Wire guided strategy - Standard of care

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.

Study summary

Recently, a new device for measuring physiological lesion severity, the pressure microcatheter, was introduced. The pressure microcatheter provides similar information to the conventional measurement technique but differs as it is easily advanced on a customary coronary wire and simplifies pullback maneuvers. The pressure microcatheter has been shown to provide comparable FFR results to pressure wires.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. The subject must be at least 18 years of age and younger than 85 years old. 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: 1. STEMI as clinical presentation. 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.

Primary outcome measure(s)

Trial sites (29)

FacilityCityRegionStatus
OLV Aalst Aalst Oost-Vlaanderen Recruiting
Universitair ziekenhuis Brussel Brussels Belgium Recruiting
ZOL Genk Belgium Recruiting
Zhongshan Hospital of Fudan University Shanghai Xuhui District Active Not Recruiting
QILU Hospital of Shandong University Shandong China Active Not Recruiting
West China Hospital of Sichuan University Sichuan China Active Not Recruiting
CHU Lille Lille France Recruiting
Claude Bernard University Lyon France Active Not Recruiting
ICPS Paris France Recruiting
Herzzentrum Dresden Dresden Germany Recruiting
Klinikum Fürth Fürth Germany Recruiting
Klinikum Herford Herford Germany Recruiting
Catholic Medical Center Koblenz-Montabaur Koblenz Germany Active Not Recruiting
Herzzentrum Lahr Lahr Germany Recruiting
Universitätsklinik Mainz Germany Recruiting
Nuovo Arcispedale S.Anna Di Ferrara Ferrara Italy Recruiting
Ospedale Civile Sant'Andrea La Spezia Italy Recruiting
Ospedale Santa Maria Goretti Latina Italy Recruiting
Azienda Ospedaliera Universitaria Federico II Naples Italy Recruiting
Azienda Ospedaliera Universitaria Sant'Andrea Rome Italy Recruiting
Amsterdam UMC Amsterdam Netherlands Recruiting
Catharina Ziekenhuis Eindhoven Netherlands Recruiting
UMCN Radboud Nijmegen Netherlands Recruiting
Dr. Jurasz University Hospital No. 1 Bydgoszcz Poland Recruiting
John Paul II Specialistic Hospital Krakow Poland Recruiting
National Cardiac Institute Warsaw Poland Recruiting
Hospital Clínic Barcelona Barcelona Spain Recruiting
Germans Trias i Pujol Hopital Barcelona Spain Recruiting
Hospital de Belvitge Barcelona Spain Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05437900 on ClinicalTrials.gov ↗ ← All trials in China