Clinical trial NCT05437900: INSIGHTFUL-FFR Clinical Trial
Official title: Pressure Microcatheter Vs Pressure Wire for Clinical Decision Making and PCI Optimization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Coronary Artery Disease
Acute Coronary Syndrome
Keywords: Percutaneous Coronary intervention (PCI)
Lead sponsor: CoreAalst BV
Sponsor class: INDUSTRY
Collaborators: name: Insight Lifetech Co., Ltd.
First posted: 2022-06-29
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Compare the rate of MACE between pressure microcatheter and pressure wire strategies.
timeFrame: 12 Months follow-up
Secondary outcomes:
measure: Compare the rate of target vessel failure (TVF) between PIOS and SOC.
timeFrame: 12 Months follow-up
measure: Compare in-hospital resource utilization between pressure microcatheter and pressure wire strategies.
timeFrame: During the hospitalisation (from admission to the hospital until discharge after the procedure)
measure: Compare the procedure time between pressure microcatheter and pressure-wire guided strategies in minutes.
timeFrame: Periprocedural time frame
measure: Compare in-hospital resource utilisation between PIOS-MC and PIOS-PW.
timeFrame: During the hospitalisation (from admission to the hospital until discharge after the procedure)
measure: In patients undergoing PCI, compare the procedural time in minutes between pressure PIOS-MC and PIOS-PW strategies.
timeFrame: Periprocedural time frame
measure: Compare the post-PCI FFR between the pressure microcatheter and pressure-wire guided strategies in patients undergoing PCI.
timeFrame: Periprocedural time frame
measure: Compare the post-PCI FFR between pressure PIOS and SOC strategies in patients undergoing PCI.
timeFrame: Periprocedural time frame
measure: Compare the post-PCI FFR between pressure PIOS-MC and PIOS-PW strategies in patients undergoing PCI.
timeFrame: Periprocedural time frame
measure: Compare the proportion of FFR > 0.90 between pressure microcatheter (MC) PIOS and SOC strategies in patients undergoing PCI.
timeFrame: Periprocedural time frame
measure: Compare the proportion of FFR > 0.80 between pressure PIOS and SOC strategies in patients undergoing PCI.
timeFrame: Periprocedural time frame
measure: Compare the proportion of FFR > 0.80 between pressure PIOS-MC and PIOS-PW strategies in patients undergoing PCI
timeFrame: Periprocedural time frame
measure: Compare the proportion of FFR > 0.90 between pressure PIOS-MC and PIOS-PW strategies in patients undergoing PCI.
timeFrame: Periprocedural time frame
measure: Compare the rate of symptoms-free status between pressure microcatheter and pressure wire strategies.
timeFrame: 12 Months follow-up
measure: Compare the rate of all-cause death between pressure microcatheter and pressure-wire guided strategies.
timeFrame: 12 Months follow-up
measure: Compare the rate of myocardial infarction between pressure microcatheter and pressure-wire guided strategies.
timeFrame: 12 Months follow-up
measure: Compare the rate of unplanned revascularisation between pressure microcatheter and pressure-wire guided strategies.
timeFrame: 12 Months follow-up
measure: In patients undergoing PCI, compare the rate of cardiac death between PIOS and SOC.
timeFrame: 12 Months follow-up
measure: In patients undergoing PCI, compare the rate of target vessel myocardial infarction (MI) between PIOS and SOC.
timeFrame: 12 Months follow-up
measure: In patients undergoing PCI, compare the rate of ischemia-driven target-vessel revascularization (ID-TVR) between PIOS and SOC.
timeFrame: 12 Months follow-up
measure: Compare the rate of PCI-related myocardial infarction (MI) (type 4a) between pressure PIOS and SOC.
timeFrame: During the procedure
measure: Compare the rate of angiographic complications between pressure microcatheter and pressure-wire guided strategies.
timeFrame: Periprocedural time frame
measure: Compare the predictive capacity of the PPG derived from pressure microcatheter versus pressure wire for post-PCI FFR.
timeFrame: Periprocedural time frame
measure: Compare the predictive capacity of the PPG derived from pressure microcatheter versus pressure wire for target vessel failure (TVF).
timeFrame: 12 Months follow-up
measure: Compare the predictive capacity of the PPG derived from pressure microcatheter versus pressure wire for target-vessel myocardial infarction (MI).
timeFrame: 12 Months follow-up
measure: Compare the predictive capacity of the PPG derived from pressure microcatheter versus pressure wire for ischemia-driven target-vessel revascularization (ID-TVR).
timeFrame: 12 Months follow-up
measure: Compare the predictive capacity of the post-PCI residual pressure gradients from pressure microcatheter versus pressure wire for target-vessel myocardial infarction (MI).
timeFrame: 12 Months follow-up
measure: Compare the predictive capacity of the post-PCI residual pressure gradients from pressure microcatheter versus pressure wire for target vessel revascularization.
timeFrame: 12 Months follow-up
measure: Compare the rate of peri-procedural myocardial infarction stratified by PPG derived from pressure microcatheter versus pressure wire.
timeFrame: Periprocedural timeframe
measure: Compare the rate of peri-procedural myocardial injury stratified by PPG derived from pressure microcatheter versus pressure wire.
timeFrame: Periprocedural timeframe
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Aalst
state: Oost-Vlaanderen
city: Brussel
country: Belgium
facility: Universitair ziekenhuis Brussel
city: Genk
country: Belgium
facility: ZOL
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
state: Xuhui District
city: Shandong
country: China
facility: QILU Hospital of Shandong University
city: Sichuan
country: China
facility: West China Hospital of Sichuan University
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: Claude Bernard University
city: Paris
country: France
facility: ICPS
city: Dresden
country: Germany
facility: Herzzentrum Dresden
city: Fürth
country: Germany
facility: Klinikum Fürth
city: Herford
country: Germany
facility: Klinikum Herford
city: Koblenz
country: Germany
facility: Catholic Medical Center Koblenz-Montabaur
city: Lahr
country: Germany
facility: Herzzentrum Lahr
city: Mainz
country: Germany
facility: Universitätsklinik
city: Ferrara
country: Italy
facility: Nuovo Arcispedale S.Anna Di Ferrara
city: La Spezia
country: Italy
facility: Ospedale Civile Sant'Andrea
city: Latina
country: Italy
facility: Ospedale Santa Maria Goretti
city: Naples
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Rome
country: Italy
facility: Azienda Ospedaliera Universitaria Sant'Andrea
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Nijmegen
country: Netherlands
facility: UMCN Radboud
city: Bydgosz
country: Poland
facility: Dr. Jurasz University Hospital No. 1
city: Krakow
country: Poland
facility: John Paul II Specialistic Hospital
city: Poznan
country: Poland
facility: Uniwersitecki Szpital Kliniczny w Poznan
city: Rzeszow
country: Poland
facility: MSWIA Hospital Rzeszow
city: Warsaw
country: Poland
facility: National Cardiac Institute
city: Barcelona
country: Spain
facility: Hospital Clínic Barcelona
city: Barcelona
country: Spain
facility: Germans Trias i Pujol Hopital
city: Barcelona
country: Spain
facility: Hospital de Belvitge
Study officials:
affiliation: Azienda Ospedaliera Universitaria Sant'Andrea, Roma
name: Emanuele Barbato, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: OLV Aalst
name: Carlos Collet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Hospital, Fudan University, Shanghai
name: Junbo Ge, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Salvatore Brugaletta, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: