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Coronary Artery DiseasePhase 4NCT05437900

INSIGHTFUL-FFR Clinical Trial

A Phase 4 study testing Pressure Microcatheter guided strategy - PIOS MC and Pressure Wire guided strategy - PIOS - PW in people with Coronary Artery Disease and Acute Coronary Syndrome, run by CoreAalst BV at 29 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Pressure Microcatheter guided strategy - PIOS MC and Pressure Wire guided strategy - PIOS - PW
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,500 participants
Where
29 sitesin 8 countries
Study dates
22 Sep 2022to 30 Jun 2030
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.
  • The subject has a documented or suspected hepatic disorder defined as cirrhosis or Child-Pugh ≥ Class B.
  • 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.
  • The subject is currently participating in another investigational drug or device clinical study.
  • Pregnancy or nursing.
  • 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.

Trial locations and contacts

29 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Sofie Pardaens contact

0032 53 72 42 30

sofiepardaens@coreaalst.com

29 sites in 8 countries

Germany6 sites, 5 recruiting

  • Herzzentrum Dresden

    Dresden

    Felix Woitek, MD

    Felix Woitek

    Recruiting

  • Klinikum Fürth

    Fürth

    Stylianos Pyxaras, MD,PhD

    Stylianos Pyxaras, MD, PhD

    Recruiting

  • Klinikum Herford

    Herford

    Dominik Gorski, MD

    Dominik Gorski, MD

    Recruiting

  • Catholic Medical Center Koblenz-Montabaur

    Koblenz

    Active, not recruiting

  • Herzzentrum Lahr

    Lahr

    Kambis Mashayekhi, MD, PhD

    Kambis Mashayekhi, MD, PhD

    Recruiting

  • Universitätsklinik

    Mainz

    Tommaso Gori, MD, PhD

    Tommaso Gori, MD, PhD

    Recruiting

Other trials in Germany

Italy5 sites, 5 recruiting

  • Nuovo Arcispedale S.Anna Di Ferrara

    Ferrara

    Gianluca Campo, MD

    Gianluca Campo, MD

    Recruiting

  • Ospedale Civile Sant'Andrea

    La Spezia

    Marco Arena, MD

    Marco Arena

    Recruiting

  • Ospedale Santa Maria Goretti

    Latina

    Iginio Colaiori, MD

    Iginio Colaiori, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Naples

    Giovanni Esposito, MD

    Giovanni Esposito, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Sant'Andrea

    Rome

    Emanuele Barbato, MD

    Emanuele Barbato, MD

    Recruiting

Other trials in Italy

Belgium3 sites, 3 recruiting

  • OLV Aalst

    Aalst, Oost-Vlaanderen, 9300

    Hilde Delacroix, hilde.delacroix@olvz-aalst.be

    Carlos Collet, MD, PhD

    Recruiting

  • Universitair ziekenhuis Brussel

    Brussels

    Marnix von Kemp, Md

    Marnix von Kemp, MD

    Recruiting

  • ZOL

    Genk

    Daan Cottens, MD

    Daan Cottens, MD

    Recruiting

Other trials in Belgium

China3 sites

  • QILU Hospital of Shandong University

    Shandong

    Active, not recruiting

  • Zhongshan Hospital of Fudan University

    Shanghai, Xuhui District, 200031

    Active, not recruiting

  • West China Hospital of Sichuan University

    Sichuan

    Active, not recruiting

Other trials in China

France3 sites, 2 recruiting

  • CHU Lille

    Lille

    Eric Van Belle, MD

    Eric Van Belle, MD

    Recruiting

  • Claude Bernard University

    Lyon

    Active, not recruiting

  • ICPS

    Paris

    Nicolas Amabile, MD

    Nicolas Amabile, MD

    Recruiting

Other trials in France

Netherlands3 sites, 3 recruiting

  • Amsterdam UMC

    Amsterdam

    Marcel Beijk, MD

    Marcel Beijk, MD

    Recruiting

  • Catharina Ziekenhuis

    Eindhoven

    Pim Tonino, MD

    Pim Tonino, MD

    Recruiting

  • UMCN Radboud

    Nijmegen

    Lokien Van Nunen, MD

    Lokien Van Nunen, MD

    Recruiting

Other trials in Netherlands

Poland3 sites, 3 recruiting

  • Dr. Jurasz University Hospital No. 1

    Bydgoszcz

    Adam Sukiennik, MD

    Adam Sukiennik

    Recruiting

  • John Paul II Specialistic Hospital

    Krakow

    Jacek Legutko, MD

    Jacek Legutko, MD

    Recruiting

  • National Cardiac Institute

    Warsaw

    Adam Witkowski, MD, PhD

    Adam Witkowski, MD, PhD

    Recruiting

Other trials in Poland

Spain3 sites, 3 recruiting

  • Hospital Clínic Barcelona

    Barcelona, 08036

    Salvatore Brugaletta, MD, PhD

    Salvatore Brugaletta, MD, PhD

    Recruiting

  • Germans Trias i Pujol Hopital

    Barcelona

    Oriol Rodriguez, MD

    Oriol Rodriguez, MD

    Recruiting

  • Hospital de Belvitge

    Barcelona

    Josep Gomez Lara, MD

    Josep Gomez Lara

    Recruiting

Other trials in Spain

About this study

Official title: Pressure Microcatheter vs Pressure Wire for Clinical Decision Making and PCI Optimization

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.

Being tested
Pressure Microcatheter guided strategy - PIOS MC, Pressure Wire guided strategy - PIOS - PW, Pressure Microcatheter guided strategy - Standard of care, Pressure Wire guided strategy - Standard of care
Keywords
Percutaneous Coronary intervention (PCI)
Medical subject headings
Coronary Artery Disease, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pressure Microcatheter guided strategy - PIOS MCProcedure or surgery

    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 - PWProcedure or surgery

    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 careProcedure or surgery

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

  • Pressure Wire guided strategy - Standard of careProcedure or surgery

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

Study groups in NCT05437900
Study groupRoleWhat they receive
Pressure Microcatheter guided strategy - PIOS-MCExperimentalPatients 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).
Receives: Procedure: Pressure Microcatheter guided strategy - PIOS MC
Pressure Wire guided strategy - PIOS-PWActive comparatorPatients 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).
Receives: Procedure: Pressure Wire guided strategy - PIOS - PW
Pressure Microcatheter guided strategy - Standard of careExperimentalPatients will be treated with the Pressure Microcatheter during PCI. After completing an angiographically successful PCI, patients will receive the standard of care treatment.
Receives: Procedure: Pressure Microcatheter guided strategy - Standard of care
Pressure Wire guided strategy - Standard of careActive comparatorPatients will be treated with the Pressure Wire during PCI. After completing an angiographically successful PCI, patients will receive the standard of care treatment.
Receives: Procedure: Pressure Wire guided strategy - Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 Months follow-up

Secondary outcomes (29)

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

    In patients undergoing PCI, compare the rate of target vessel failure (TVF) defined as the composite of cardiac death, target vessel MI and ischemia-driven target vessel revascularisation (ID-TVR) between PIOS and SOC.

    Measured: 12 Months follow-up

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

    Compare in-hospital resource utilisation (cost from all the procedures during the hospitalisation to discharge in Euros) between microcatheter and pressure wire strategies i.e.number of pressure catheters/wires and procedural time needed to complete the procedure.

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

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

    Compare the procedure time between pressure microcatheter and pressure-wire guided strategies in minutes. This is the time from first to the last angiography in minutes.

    Measured: Periprocedural time frame

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

    In patients undergoing PCI, compare resource utilisation (cost from all the procedures during the hospitalisation to discharge in Euros, e.g. number of catheters/wires) between a pressure PIOS-MC and PIOS-PW strategies in patients undergoing PCI.

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

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

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

    Measured: Periprocedural time frame

  6. Compare the post-PCI FFR between the pressure microcatheter and pressure-wire guided strategies in patients undergoing PCI.

    Measured: Periprocedural time frame

  7. Compare the post-PCI FFR between pressure PIOS and SOC strategies in patients undergoing PCI.

    Measured: Periprocedural time frame

  8. Compare the post-PCI FFR between pressure PIOS-MC and PIOS-PW strategies in patients undergoing PCI.

    Measured: Periprocedural time frame

  9. Compare the proportion of FFR > 0.90 between pressure microcatheter (MC) PIOS and SOC strategies in patients undergoing PCI.

    Compare the proportion of FFR > 0.90 (in percentage) between pressure microcatheter (MC) PIOS and SOC strategies in patients undergoing PCI.

    Measured: Periprocedural time frame

  10. Compare the proportion of FFR > 0.80 between pressure PIOS and SOC strategies in patients undergoing PCI.

    Compare the proportion of FFR > 0.80 (in percentage) between pressure PIOS and SOC strategies in patients undergoing PCI.

    Measured: Periprocedural time frame

  11. Compare the proportion of FFR > 0.80 between pressure PIOS-MC and PIOS-PW strategies in patients undergoing PCI

    Compare the proportion of FFR > 0.80 (in percentage) between pressure PIOS-MC and PIOS-PW strategies in patients undergoing PCI

    Measured: Periprocedural time frame

  12. Compare the proportion of FFR > 0.90 between pressure PIOS-MC and PIOS-PW strategies in patients undergoing PCI.

    Compare the proportion of FFR > 0.90 (in percentage) between pressure PIOS-MC and PIOS-PW

    Measured: Periprocedural time frame

  13. Compare the rate of symptoms-free status between pressure microcatheter and pressure wire strategies.

    Compare the rate of symptoms-free status assessed by the Seattle Angina Questionnaire (SAQ-7) between pressure microcatheter and pressure-wire guided strategies at 12 months follow-up.

    Measured: 12 Months follow-up

  14. Compare the rate of all-cause death between pressure microcatheter and pressure-wire guided strategies.

    Compare the rate of all-cause death between pressure microcatheter and pressure-wire guided strategies at 12 months follow-up

    Measured: 12 Months follow-up

  15. Compare the rate of myocardial infarction between pressure microcatheter and pressure-wire guided strategies.

    Compare the rate of myocardial infarction between pressure microcatheter and pressure-wire guided strategies at 12 months follow-up

    Measured: 12 Months follow-up

  16. Compare the rate of unplanned revascularisation between pressure microcatheter and pressure-wire guided strategies.

    Compare the rate of unplanned revascularisation between pressure microcatheter and pressure-wire guided strategies at 12 months follow-up

    Measured: 12 Months follow-up

  17. In patients undergoing PCI, compare the rate of cardiac death between PIOS and SOC.

    In patients undergoing PCI, compare the rate of cardiac death between PIOS and SOC at 12 months follow-up

    Measured: 12 Months follow-up

  18. In patients undergoing PCI, compare the rate of target vessel myocardial infarction (MI) between PIOS and SOC.

    In patients undergoing PCI, compare the rate of target vessel myocardial infarction (MI) between PIOS and SOC at 12 months follow-up.

    Measured: 12 Months follow-up

  19. In patients undergoing PCI, compare the rate of ischemia-driven target-vessel revascularization (ID-TVR) between PIOS and SOC.

    In patients undergoing PCI, compare the rate of ischemia-driven target-vessel revascularization (ID-TVR) between PIOS and SOC at 12 months follow-up

    Measured: 12 Months follow-up

  20. Compare the rate of PCI-related myocardial infarction (MI) (type 4a) between pressure PIOS and SOC.

    Measured: During the procedure

  21. Compare the rate of angiographic complications between pressure microcatheter and pressure-wire guided strategies.

    Compare the rate of angiographic complications related to vessel wiring (i.e., Angiographic dissection ≥ NHLBI type B, perforations (Ellis classification), intra-procedural thrombotic events (including slow-flow, no-reflow, side branch closure, distal embolization, and intra-procedural stent thrombosis, as per the standard angiographic core laboratory definitions) between pressure microcatheter and pressure-wire guided strategies.

    Measured: Periprocedural time frame

  22. Compare the predictive capacity of the PPG derived from pressure microcatheter versus pressure wire for post-PCI FFR.

    Compare how close the value of PPG derived from pressure microcatheter versus pressure wire corresponds to the actual measure post-PCI FFR value.

    Measured: Periprocedural time frame

  23. Compare the predictive capacity of the PPG derived from pressure microcatheter versus pressure wire for target vessel failure (TVF).

    Compare how close the value of PPG derived from pressure microcatheter versus pressure wire corresponds to the occurence of target vessel failure (TVF).

    Measured: 12 Months follow-up

  24. Compare the predictive capacity of the PPG derived from pressure microcatheter versus pressure wire for target-vessel myocardial infarction (MI).

    Compare how close the value of PPG derived from pressure microcatheter versus pressure wire corresponds to the occurence of target myocardial infarction.

    Measured: 12 Months follow-up

  25. Compare the predictive capacity of the PPG derived from pressure microcatheter versus pressure wire for ischemia-driven target-vessel revascularization (ID-TVR).

    Compare how close the value of PPG derived from pressure microcatheter versus pressure wire corresponds to the occurence of ischemia-driven target-vessel revascularization (ID-TVR).

    Measured: 12 Months follow-up

  26. Compare the predictive capacity of the post-PCI residual pressure gradients from pressure microcatheter versus pressure wire for target-vessel myocardial infarction (MI).

    Compare how close the post-PCI residual pressure gradients from pressure microcatheter versus pressure wire corresponds to the occurence of target-vessel myocardial infarction (MI).

    Measured: 12 Months follow-up

  27. Compare the predictive capacity of the post-PCI residual pressure gradients from pressure microcatheter versus pressure wire for target vessel revascularization.

    Compare how close the post-PCI residual pressure gradients from pressure microcatheter versus pressure wire corresponds to the occurence of target-vessel revascularization.

    Measured: 12 Months follow-up

  28. Compare the rate of peri-procedural myocardial infarction stratified by PPG derived from pressure microcatheter versus pressure wire.

    Measured: Periprocedural timeframe

  29. Compare the rate of peri-procedural myocardial injury stratified by PPG derived from pressure microcatheter versus pressure wire.

    Measured: Periprocedural timeframe

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2022
  2. Study start22 Sep 2022
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
2,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05437900
Sponsor's protocol ID
CA-053
Status last verified
Jan 2026
First submitted
2 Jun 2022
Last updated
12 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41195772

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pressure Microcatheter guided strategy - PIOS MC and Pressure Wire guided strategy - PIOS - PW in people with Coronary Artery Disease and Acute Coronary Syndrome, run by CoreAalst BV at 29 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Germany, Italy, Belgium, China, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sofie Pardaens (0032 53 72 42 30, sofiepardaens@coreaalst.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the rate of MACE between pressure microcatheter and pressure wire strategies. (time frame: 12 Months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05437900, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

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