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Precise Procedural and PCI Plan (P4) (P4)

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CT-guided PCI
IVUS-guided PCI
Sponsored by
CoreAalst BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The subject must be at least 18 years of age and younger than 80 years old.
  2. Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for elective PCI.
  3. Patients with a clinical indication for revascularization presenting with stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression>1mm in ≥6 leads plus ST-segment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score>140.
  4. All target lesions must be planned for treatment only in vessels with RVD ≥2.5 mm and ≤4.0 mm.
  5. No more than 2 target vessels are allowed. A bifurcation counts as a single lesion even if the side branch is planned to be treated.
  6. Subject must provide written Informed Consent before any study-related procedure.

Exclusion Criteria:

  1. Age <18 years or ≥80 years old
  2. STEMI as clinical presentation.
  3. Uncontrolled or recurrent ventricular tachycardia.
  4. Hemodynamic instability.
  5. Severe renal dysfunction, defined as an eGFR ≤30 mL/min/1.73 m2.
  6. Atrial fibrillation, flutter, or arrhythmias.
  7. Previous PCI or CABG.
  8. The target lesion is in the left main coronary artery
  9. BMI ≥35 kg/m2.
  10. Insufficient CT quality assessed by the Core lab.
  11. Comorbidity with life expectancy ≤ 2 years.
  12. 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 6 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.
  13. Planned major cardiac or non-cardiac surgery within 24 months after the index procedure Note: Major surgery is any invasive operative 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.
  14. Prior PCI within the target vessel within 12 months.
  15. 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.
  16. The subject has received a solid organ transplant that is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.
  17. 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.
  18. The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum.
  19. Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
  20. The subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  21. 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, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy <2 years for any non-cardiac cause.
  22. Subject is currently participating in another investigational drug or device clinical study.
  23. Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
  24. 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.
  25. Unable to provide written informed consent (IC).

Sites / Locations

  • UZ BrusselsRecruiting
  • OLV HospitalRecruiting
  • Hartcentrum ZNA AntwerpRecruiting
  • Gentofte hospitalRecruiting
  • Aarhus UniversitetshospitalRecruiting
  • RigshospitaletRecruiting
  • Medical Imaging Centre, Semmelweis UniversityRecruiting
  • Humanitas University
  • Ospedale Galeazzi Sant'Ambrogio
  • Ospedale Molinette
  • Royal Bournemouth Hospital
  • Oxford University Hospital NHS Foundation Trust
  • Golden Jubilee National Hospital
  • Liverpool Heart and Chest Hospital
  • Freeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CT-guided PCI strategy

intravascular ultrasound (IVUS)-guided PCI strategy

Arm Description

QAngio CT Research Edition is a software suite providing several functionalities for the analysis of coronary computed tomography angiography (CCTA) scans to extract and present relevant information on the coronary vasculature for further clinical investigation. Also, QAngio CT Research Edition allows to export this information for later viewing during x-ray angiography (XA) procedures to help physicians plan and guide the interventional procedure.

Intravascular ultrasound (IVUS) is an invasive intravascular imaging technique able to visualize the coronary vessel. The use of IVUS-guided PCI has been endorsed an recommended by the European Society of Cardiology. The device is considered part of standard of clinical care.

Outcomes

Primary Outcome Measures

rate of MACE between CCTA- and IVUS-guided PCI strategy
Comparison of the rate of the composite of major adverse cardiovascular events, defined as cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization between CT- and IVUS-guided PCI strategies at 12-month follow-up

Secondary Outcome Measures

Compare in-hospital resource utilization between CCTA- and IVUS-guided PCI strategies.
Compare in-hospital resource utilization (cost from all the procedures during the hospitalisation to discharge in Euros) between CCTA- and IVUS-guided PCI strategies.
Compare resource utilization at 12-month follow-up between CCTA- and IVUS-guided PCI strategies
Compare resource utilization (procedural cost and cost from additional interventions in Euros) at 12-month follow-up between CCTA- and IVUS-guided PCI
Compare radiation dose (defined as radiation dose from the invasive procedure) between CCTA- and IVUS- guided PCI strategies.
Compare contrast volume (defined as contrast volume used during the invasive procedure) between CCTA- and IVUS- guided PCI strategies.
Compare the rate of cardiac death between CCTA- and IVUS-guided PCI strategies.
Compare the rate of target-vessel myocardial infarction between CCTA- and IVUS-guided PCI strategies.
Compare the rate of ischemia-driven target-vessel revascularization between CCTA- and IVUS-guided PCI strategies.
Compare the rate of PCI-related MI (type 4a a, 4th Universal Definition of MI) between CCTA- and IVUS-guided PCI strategies
Compare the degree of functional revascularization, defined by post-PCI FFR values measured immediately after PCI between CCTA- and IVUS-guided PCI strategies.
Compare the degree of functional revascularization, defined by FFRCT Planner, between CCTA- and IVUS-guided PCI strategies.
Compare the rate of MACE between patient with complete and incomplete functional revascularization based on the FFRCT Planner, at 12-month follow-up.
Compare the rate of MACE between patient with complete and incomplete functional revascularization based on the post-PCI FFR values measured immediately after PCI, at 12-month follow-up.
Assess the agreement on post-PCI FFR between the FFRCT Planner and the invasive measurement.
Assess the agreement between the FFRCT Planner strategy and the actual treatment performed.
Assess the CCTA predictors of stent under expansion.
To assess which characteristics of the plaque, defined by CT, can predict whether the stent is under expansion (by multivariate analysis on the data)
To compare angiographic Endpoints (Core Lab assessed QCA): - Final (post-PCI) minimal lumen diameter. - Final (post-PCI) percent diameter stenosis. - Acute lumen gain post-intervention.
To compare the maximum device size (stent or post-dilatation balloon)/reference vessel diameter ratio) CCTA- and IVUS-guided PCI strategies.
To compare angiographic complications CCTA- and IVUS guided PCI strategies.
Angiographic dissection ≥ NHLBI type B, perforations (Ellis's 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
To compare procedural time (defined as the time from first to the last angiography) between CCTA- and IVUS-guided PCI strategies.
Compare the rate of symptoms-free status assessed by the SAQ-7 between CCTA- and IVUS-guided PCI strategies at 12-months.
Compare the change in symptoms assessed by the change of Seattle Angina Questionnaire (SAQ-7) scores between CCTA- and IVUS-guided PCI strategies at 12-months.
Compare the change in symptoms assessed by the change of EuroQol 5 dimensions - 5 levels (EQ-5D-5L) scores between CCTA- and IVUS-guided PCI strategies at 12-months.
Assess the capacity of the FFRCT Planner (predicted post-PCI FFR) to predict adverse events.
Assess whether the predicted post-PCI FFR value which is calculated by the FFRCT-planner can predict adverse outcomes

Full Information

First Posted
December 6, 2021
Last Updated
August 16, 2023
Sponsor
CoreAalst BV
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1. Study Identification

Unique Protocol Identification Number
NCT05253677
Brief Title
Precise Procedural and PCI Plan (P4)
Acronym
P4
Official Title
Precise Procedural and PCI Plan (P4) Randomized Clinical Trial Integration of Coronary Computed Tomography Angiography in the Catheterization Laboratory to Plan and Guide Coronary Percutaneous Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CoreAalst BV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Computed tomography (CT) has become an established tool in the diagnostic workup of patients with suspected coronary artery disease (CAD). The availability of coronary CT angiography (CCTA) before the invasive procedure allows stratifying case complexity and can be used to improve patient selection for PCI, to plan and guide therapeutic interventions. Beyond the diagnostic and therapeutic phase, it helps to better organize the catheterization laboratory workflow. The P4 study is an investigator-initiated, multicenter, randomized study with a non-inferiority design of patients with an indication for PCI aiming at comparing clinical outcomes between two imaging strategies to guide PCI, being coronary CT-guided PCI strategy (investigational technology) and IVUS-guided PCI strategy (comparator). After identifying the presence of a significant coronary stenosis, the patient will be randomized either to CT- or IVUS-guided PCI groups. Both CT and IVUS-guided PCI will be performed following the P4 trial protocol. When the procedure is completed, post-PCI FFR will be measured. All patients will be followed in hospital, at 30 days (±15 days), 12 months (±1 month) and yearly until 5 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CT-guided PCI strategy
Arm Type
Experimental
Arm Description
QAngio CT Research Edition is a software suite providing several functionalities for the analysis of coronary computed tomography angiography (CCTA) scans to extract and present relevant information on the coronary vasculature for further clinical investigation. Also, QAngio CT Research Edition allows to export this information for later viewing during x-ray angiography (XA) procedures to help physicians plan and guide the interventional procedure.
Arm Title
intravascular ultrasound (IVUS)-guided PCI strategy
Arm Type
Active Comparator
Arm Description
Intravascular ultrasound (IVUS) is an invasive intravascular imaging technique able to visualize the coronary vessel. The use of IVUS-guided PCI has been endorsed an recommended by the European Society of Cardiology. The device is considered part of standard of clinical care.
Intervention Type
Device
Intervention Name(s)
CT-guided PCI
Intervention Description
CT-guided PCI with standardized pre-procedural planning and online guidance.
Intervention Type
Device
Intervention Name(s)
IVUS-guided PCI
Intervention Description
use of IVUS during PCI procedure (standard of care)
Primary Outcome Measure Information:
Title
rate of MACE between CCTA- and IVUS-guided PCI strategy
Description
Comparison of the rate of the composite of major adverse cardiovascular events, defined as cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization between CT- and IVUS-guided PCI strategies at 12-month follow-up
Time Frame
12 months follow-up
Secondary Outcome Measure Information:
Title
Compare in-hospital resource utilization between CCTA- and IVUS-guided PCI strategies.
Description
Compare in-hospital resource utilization (cost from all the procedures during the hospitalisation to discharge in Euros) between CCTA- and IVUS-guided PCI strategies.
Time Frame
during the intervention
Title
Compare resource utilization at 12-month follow-up between CCTA- and IVUS-guided PCI strategies
Description
Compare resource utilization (procedural cost and cost from additional interventions in Euros) at 12-month follow-up between CCTA- and IVUS-guided PCI
Time Frame
12 months follow-up
Title
Compare radiation dose (defined as radiation dose from the invasive procedure) between CCTA- and IVUS- guided PCI strategies.
Time Frame
periprocedural time frame
Title
Compare contrast volume (defined as contrast volume used during the invasive procedure) between CCTA- and IVUS- guided PCI strategies.
Time Frame
periprocedural time frame
Title
Compare the rate of cardiac death between CCTA- and IVUS-guided PCI strategies.
Time Frame
12 months follow-up
Title
Compare the rate of target-vessel myocardial infarction between CCTA- and IVUS-guided PCI strategies.
Time Frame
12 months follow-up
Title
Compare the rate of ischemia-driven target-vessel revascularization between CCTA- and IVUS-guided PCI strategies.
Time Frame
12 months follow-up
Title
Compare the rate of PCI-related MI (type 4a a, 4th Universal Definition of MI) between CCTA- and IVUS-guided PCI strategies
Time Frame
during the procedure
Title
Compare the degree of functional revascularization, defined by post-PCI FFR values measured immediately after PCI between CCTA- and IVUS-guided PCI strategies.
Time Frame
periprocedural time frame
Title
Compare the degree of functional revascularization, defined by FFRCT Planner, between CCTA- and IVUS-guided PCI strategies.
Time Frame
periprocedural time frame
Title
Compare the rate of MACE between patient with complete and incomplete functional revascularization based on the FFRCT Planner, at 12-month follow-up.
Time Frame
12 months follow-up
Title
Compare the rate of MACE between patient with complete and incomplete functional revascularization based on the post-PCI FFR values measured immediately after PCI, at 12-month follow-up.
Time Frame
12 months follow-up
Title
Assess the agreement on post-PCI FFR between the FFRCT Planner and the invasive measurement.
Time Frame
periprocedural time frame
Title
Assess the agreement between the FFRCT Planner strategy and the actual treatment performed.
Time Frame
periprocedural time frame
Title
Assess the CCTA predictors of stent under expansion.
Description
To assess which characteristics of the plaque, defined by CT, can predict whether the stent is under expansion (by multivariate analysis on the data)
Time Frame
periprocedural time frame
Title
To compare angiographic Endpoints (Core Lab assessed QCA): - Final (post-PCI) minimal lumen diameter. - Final (post-PCI) percent diameter stenosis. - Acute lumen gain post-intervention.
Time Frame
periprocedural time frame
Title
To compare the maximum device size (stent or post-dilatation balloon)/reference vessel diameter ratio) CCTA- and IVUS-guided PCI strategies.
Time Frame
periprocedural time frame
Title
To compare angiographic complications CCTA- and IVUS guided PCI strategies.
Description
Angiographic dissection ≥ NHLBI type B, perforations (Ellis's 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
Time Frame
periprocedural time frame
Title
To compare procedural time (defined as the time from first to the last angiography) between CCTA- and IVUS-guided PCI strategies.
Time Frame
periprocedural time frame
Title
Compare the rate of symptoms-free status assessed by the SAQ-7 between CCTA- and IVUS-guided PCI strategies at 12-months.
Time Frame
12 months follow-up
Title
Compare the change in symptoms assessed by the change of Seattle Angina Questionnaire (SAQ-7) scores between CCTA- and IVUS-guided PCI strategies at 12-months.
Time Frame
12 months follow-up
Title
Compare the change in symptoms assessed by the change of EuroQol 5 dimensions - 5 levels (EQ-5D-5L) scores between CCTA- and IVUS-guided PCI strategies at 12-months.
Time Frame
12 months follow-up
Title
Assess the capacity of the FFRCT Planner (predicted post-PCI FFR) to predict adverse events.
Description
Assess whether the predicted post-PCI FFR value which is calculated by the FFRCT-planner can predict adverse outcomes
Time Frame
12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject must be at least 18 years of age and younger than 80 years old. Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for elective PCI. Patients with a clinical indication for revascularization presenting with stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression>1mm in ≥6 leads plus ST-segment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score>140. All target lesions must be planned for treatment only in vessels with RVD ≥2.5 mm and ≤4.0 mm. No more than 2 target vessels are allowed. A bifurcation counts as a single lesion even if the side branch is planned to be treated. Subject must provide written Informed Consent before any study-related procedure. Exclusion Criteria: Age <18 years or ≥80 years old STEMI as clinical presentation. Uncontrolled or recurrent ventricular tachycardia. Hemodynamic instability. Severe renal dysfunction, defined as an eGFR ≤30 mL/min/1.73 m2. Atrial fibrillation, flutter, or arrhythmias. Previous PCI or CABG. The target lesion is in the left main coronary artery BMI ≥35 kg/m2. Insufficient CT quality assessed by the Core lab. 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 6 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 operative 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. Prior PCI within the target vessel within 12 months. 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 solid organ transplant that is functioning 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 as 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, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy <2 years for any non-cardiac cause. Subject is currently participating in another investigational drug or device clinical study. Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test. 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. Unable to provide written informed consent (IC).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Sophie Rowies, MSc
Phone
0032 53 72 42 30
Email
annesophierowies@coreaalst.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sofie Pardaens, MSc, PhD
Email
sofiepardaens@coreaalst.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Collet Bortone, MD, PhD
Organizational Affiliation
CoreAalst BV
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniele Andreini, MD, PhD
Organizational Affiliation
Milan University, Milan, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussels
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernard Cosyns, MD, PhD
Facility Name
OLV Hospital
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeroen Sonck, MD, PhD
Facility Name
Hartcentrum ZNA Antwerp
City
Antwerp
ZIP/Postal Code
2000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Zivelonghi, MD, PhD
Facility Name
Gentofte hospital
City
Gentofte
State/Province
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bettina Løjmand Mark
Email
bettina.loejmand.mark@regionh.dk
First Name & Middle Initial & Last Name & Degree
Niels T Olsen, MD, PhD
Facility Name
Aarhus Universitetshospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bjarne Norgaard, MD, PhD
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Engstroem, MD, PhD
Facility Name
Medical Imaging Centre, Semmelweis University
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pàl M Maurovitch, MD, PhD
Facility Name
Humanitas University
City
Milan
ZIP/Postal Code
20090
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giulio Stefanini, MD, PhD
Facility Name
Ospedale Galeazzi Sant'Ambrogio
City
Milan
ZIP/Postal Code
20149
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniele Andreini, MD, PhD
Facility Name
Ospedale Molinette
City
Turin
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabirizio D'Ascenzo, MD, PhD
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter O'Kane, MD, PhD
Facility Name
Oxford University Hospital NHS Foundation Trust
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Luigi De Maria, MD, PhD
Facility Name
Golden Jubilee National Hospital
City
Clydebank
ZIP/Postal Code
G81 4DY,
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colin Berry, MD, PhD
Facility Name
Liverpool Heart and Chest Hospital
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Fairbairn, MD, PhD
Facility Name
Freeman Hospital
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Bagnall, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Precise Procedural and PCI Plan (P4)

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