Comparing two methods for guiding heart procedures in patients with coronary artery disease

Pressure Microcatheter vs Pressure Wire for Clinical Decision Making and PCI Optimization

This study is testing if using a new type of pressure tool for heart procedures can work just as well as the traditional method for patients with coronary artery disease.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2500 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: CoreAalst BV (Industry-sponsored)
• Locations: 29 sites (Aalst, Oost-Vlaanderen and 28 other locations)
• Trial ID: NCT05437900 on ClinicalTrials.gov

What this trial studies

The INSIGHTFUL-FFR trial is a multicenter, randomized, open-label study that aims to evaluate the clinical outcomes of using a pressure microcatheter compared to a traditional pressure wire for guiding percutaneous coronary interventions (PCI) in patients with stable coronary artery disease or stabilized acute coronary syndrome. The trial will involve patients eligible for elective PCI and will assess whether the pressure microcatheter provides non-inferior results in clinical decision-making. Participants will be randomly assigned to receive either the pressure microcatheter-guided strategy or the pressure wire-guided strategy. The study seeks to simplify the procedure while maintaining accuracy in measuring lesion severity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with stable angina or stabilized non-ST elevation acute coronary syndrome who are eligible for elective PCI.

Not a fit: Patients presenting with STEMI, chronic total occlusions, or significant contraindications to adenosine administration may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a more efficient and less invasive method for guiding heart procedures, improving patient outcomes.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.

Eligibility criteria

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.

Where this trial is running

Aalst, Oost-Vlaanderen and 28 other locations

• OLV Aalst — Aalst, Oost-Vlaanderen, Belgium (Recruiting)
• Universitair ziekenhuis Brussel — Brussels, Belgium (Recruiting)
• Zol — Genk, Belgium (Recruiting)
• Zhongshan Hospital of Fudan University — Shanghai, Xuhui District, China (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)

Study contacts

• Principal investigator: Emanuele Barbato, MD, PhD — Azienda Ospedaliera Universitaria Sant'Andrea, Roma
• Study coordinator: Sofie Pardaens

Conditions Coronary Artery Disease; Acute Coronary Syndrome; Percutaneous Coronary intervention