INSIGHTFUL-FFR Clinical Trial

NCT05437900 | Recruiting Phase 4

• 1 other identifier: CA-053
• Study Type: interventional
• Target: 2,500
• Locations: 8 countries
• Sites: 29

Brief 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.

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Keywords

Percutaneous Coronary intervention (PCI)

Outcome Measures

Primary Outcomes (1)

• Compare the rate of MACE between pressure microcatheter and pressure wire strategies.

  Compare the rate of major adverse cardiovascular events (MACE) defined as the combined rate of all cause death, myocardial infarction (MI), and unplanned revascularization between pressure microcatheter and pressure wire strategies at 12-months follow-up.

  12 Months follow-up

Secondary Outcomes (29)

• Compare the rate of target vessel failure (TVF) between PIOS and SOC.

  12 Months follow-up

• Compare in-hospital resource utilization between pressure microcatheter and pressure wire strategies.

  During the hospitalisation (from admission to the hospital until discharge after the procedure)

• Compare the procedure time between pressure microcatheter and pressure-wire guided strategies in minutes.

  Periprocedural time frame

• Compare in-hospital resource utilisation between PIOS-MC and PIOS-PW.

  During the hospitalisation (from admission to the hospital until discharge after the procedure)

• In patients undergoing PCI, compare the procedural time in minutes between pressure PIOS-MC and PIOS-PW strategies.

  Periprocedural time frame

Study Arms (4)

Pressure Microcatheter guided strategy - PIOS-MC

EXPERIMENTAL

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).

Procedure: Pressure Microcatheter guided strategy - PIOS MC

Pressure Wire guided strategy - PIOS-PW

ACTIVE COMPARATOR

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).

Procedure: Pressure Wire guided strategy - PIOS - PW

Pressure Microcatheter guided strategy - Standard of care

EXPERIMENTAL

Patients will be treated with the Pressure Microcatheter during PCI. After completing an angiographically successful PCI, patients will receive the standard of care treatment.

Procedure: Pressure Microcatheter guided strategy - Standard of care

Pressure Wire guided strategy - Standard of care

ACTIVE COMPARATOR

Patients will be treated with the Pressure Wire during PCI. After completing an angiographically successful PCI, patients will receive the standard of care treatment.

Procedure: Pressure Wire guided strategy - Standard of care

Interventions

Pressure Wire guided strategy - PIOS - PW PROCEDURE

Use of Pressure Wire during PCI. After the PCI, the patient will receive treatment according to the incremental optimization strategy (PIOS) .

Pressure Wire guided strategy - PIOS-PW

Pressure Microcatheter guided strategy - PIOS MC PROCEDURE

Use of Pressure Microcatheter during PCI. After the PCI, the patient will receive treatment according to the incremental optimization strategy (PIOS) .

Pressure Microcatheter guided strategy - PIOS-MC

Pressure Microcatheter guided strategy - Standard of care PROCEDURE

Use of Pressure Microcatheter during PCI. After the PCI, the patient will receive standard of care treatment.

Pressure Microcatheter guided strategy - Standard of care

Pressure Wire guided strategy - Standard of care PROCEDURE

Use of Pressure Wire during PCI. After the PCI, the patient will receive standard of care treatment.

Pressure Wire guided strategy - Standard of care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject must be at least 18 years of age and younger than 85 years old.
• Eligible for elective PCI.
• Stable angina or ACS (non-culprit vessels only and outside of primary intervention during acute STEMI)
• Subject willing to participate and able to understand, read and sign the Informed Consent.

You may not qualify if:

• STEMI as clinical presentation.
• Chronic total occlusion as a target vessel.
• Significant contraindication to adenosine administration (e.g. heart block, severe asthma)
• Uncontrolled or recurrent ventricular tachycardia.
• Hemodynamic instability.
• Severe valvular disease.
• Severe renal dysfunction defined as an eGFR ≤30 mL/min/1.73 m2.
• Comorbidity with life expectancy ≤ 2 years.
• 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.
• 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.
• 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.
• 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.
• 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.
• The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum.
• Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3.

Sponsors & Collaborators

• CoreAalst BV: lead
• Insight Lifetech Co., Ltd.: collaborator

Study Sites (29)

OLV Aalst

Aalst, Oost-Vlaanderen, 9300, Belgium

RECRUITING

Universitair ziekenhuis Brussel

Brussels, Belgium

RECRUITING

ZOL

Genk, Belgium

RECRUITING

Zhongshan Hospital of Fudan University

Shanghai, Xuhui District, 200031, 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, 08036, Spain

RECRUITING

Germans Trias i Pujol Hopital

Barcelona, Spain

RECRUITING

Hospital de Belvitge

Barcelona, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 41195772 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Emanuele Barbato, MD, PhD

  Azienda Ospedaliera Universitaria Sant'Andrea, Roma

  PRINCIPAL INVESTIGATOR

• Carlos Collet, MD, PhD

  CoreAalst BV

  PRINCIPAL INVESTIGATOR

• Junbo Ge, MD

  Zhongshan Hospital, Fudan University, Shanghai

  PRINCIPAL INVESTIGATOR

• Salvatore Brugaletta, MD, PhD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sofie Pardaens

CONTACT

0032 53 72 42 30; sofiepardaens@coreaalst.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients with one or more coronary stenoses will be randomized to either pressure microcatheter or pressure wire-based strategies for clinical decision making. Clinical decision making for PCI could be based either on FFR or NHPR. FFR or NHPR will support clinical decisions to defer or treat at the operator discretion. In cases with a positive FFR (≤ 0.80) or NHPR (≤0.89), patients will undergo a hyperemic FFR pullback to guide the PCI procedure further. PCI will be performed using last-generation drug-eluting stents (DES) at operator's discretion. After completing an angiographically successful PCI, patients will be randomized to FFR-guided stent optimization (PIOS) or standard of care (SOC). 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.

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 29, 2022
• Study Start: September 22, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2030
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3); BE (3); PL (3); ES (3); NL (3); FR (3); DE (6); IT (5)