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Direct Complete Versus Staged Complete Revascularization in Patients Presenting With Acute Coronary Syndromes and Multivessel Disease (BioVasc)

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ClinicalTrials.gov Identifier: NCT03621501
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
Biotronik SE & Co. KG
Information provided by (Responsible Party):
Roberto Diletti, Erasmus Medical Center

Brief Summary:
To test whether immediate complete revascularization is non-inferior to staged (but within six weeks after index procedure) complete revascularization in Patients presenting with ACS, including Non-ST-elevation ACS (NSTEACS) and ST-elevation myocardial infarction (STEMI), with multivessel disease accepted for PCI

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Device: Percutaneous coronary intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is a prospective, multicenter, randomized, two-arm, international, open-label, non-inferiority study. Due to the design characteristics of the study, the study investigators and operators cannot be blinded.
Masking: Single (Outcomes Assessor)
Masking Description: The clinical event adjudication committee, consisting of cardiologists who are not participating in the study, will be blinded for the treatment arm of the patients to avoid a potential bias in the adjudication process of events
Primary Purpose: Treatment
Official Title: Percutaneous Complete Revascularization Strategies Using Sirolimus Eluting Biodegradable Polymer Coated Stents in Patients Presenting With Acute Coronary Syndromes and Multivessel Disease
Actual Study Start Date : June 22, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Placebo Comparator: Staged complete revascularization
• Culprit only + staged (within six weeks after index procedure) complete revascularization in all vessels ≥ 2.5mm with ≥ 50% stenosis by visual estimation or QCA (Control arm). Functional assessment with FFR/iFR will be at operator's discretion
Device: Percutaneous coronary intervention
At the index procedure, the culprit lesion (cause of complaints/acute coronary syndrome) will be treated according to standard of care with a Biotronik Orsiro DES (Sirolimus-Eluting stent). If there are additional significant lesions besides the culprit lesion, patients will be randomized to direct complete revascularization or staged complete revascularization. In the direct complete revascularization group all lesions will be treated during the index procedure. In the staged complete revascularization group, only the culprit lesion will be treated during the index procedure. The remaining significant lesions will be treated later but within six weeks after the index procedure. In both arms the additional lesions will also be treated with Biotronik Orsiro DES (Sirolimus-Eluting stent).
Other Name: PCI

Active Comparator: Immediate complete revascularization
• Immediate complete revascularization in all vessels ≥ 2.5mm with ≥ 50% stenosis by visual estimation or QCA (Experimental arm). Functional assessment with FFR/iFR will be at operator's discretion
Device: Percutaneous coronary intervention
At the index procedure, the culprit lesion (cause of complaints/acute coronary syndrome) will be treated according to standard of care with a Biotronik Orsiro DES (Sirolimus-Eluting stent). If there are additional significant lesions besides the culprit lesion, patients will be randomized to direct complete revascularization or staged complete revascularization. In the direct complete revascularization group all lesions will be treated during the index procedure. In the staged complete revascularization group, only the culprit lesion will be treated during the index procedure. The remaining significant lesions will be treated later but within six weeks after the index procedure. In both arms the additional lesions will also be treated with Biotronik Orsiro DES (Sirolimus-Eluting stent).
Other Name: PCI




Primary Outcome Measures :
  1. MACCE [ Time Frame: 1 year ]
    a composite clinical outcome of all-cause mortality, nonfatal type 1 myocardial infarction, any unplanned revascularization, and cerebrovascular events


Secondary Outcome Measures :
  1. MACCE [ Time Frame: 30 days ]
    Composite clinical outcome of all-cause mortality, nonfatal type 1 myocardial infarction, any unplanned revascularization, and cerebrovascular events

  2. MACCE [ Time Frame: 2 years ]
    Composite clinical outcome of all-cause mortality, nonfatal type 1 myocardial infarction, any unplanned revascularization, and cerebrovascular events

  3. MACCE [ Time Frame: 5 years ]
    Composite clinical outcome of all-cause mortality, nonfatal type 1 myocardial infarction, any unplanned revascularization, and cerebrovascular events

  4. All cause mortality [ Time Frame: 30 days ]
    All cause mortality

  5. All cause mortality [ Time Frame: 1 year ]
    All cause mortality

  6. All cause mortality [ Time Frame: 2 years ]
    All cause mortality

  7. All cause mortality [ Time Frame: 5 years ]
    All cause mortality

  8. Myocardial infarction [ Time Frame: 30 days ]
    Myocardial Infarction

  9. Myocardial infarction [ Time Frame: 1 year ]
    Myocardial Infarction

  10. Myocardial infarction [ Time Frame: 2 years ]
    Myocardial Infarction

  11. Myocardial infarction [ Time Frame: 5 years ]
    Myocardial Infarction

  12. Coronary revascularization [ Time Frame: 30 days ]
    Any unplanned coronary revascularization procedure

  13. Coronary revascularization [ Time Frame: 1 year ]
    Any unplanned coronary revascularization procedure

  14. Coronary revascularization [ Time Frame: 2 years ]
    Any unplanned coronary revascularization procedure

  15. Coronary revascularization [ Time Frame: 5 years ]
    Any unplanned coronary revascularization procedure

  16. Major bleeding [ Time Frame: 30 days ]
    Major bleeding (not related to coronary-artery bypass grafting, BARC 3-5)

  17. Major bleeding [ Time Frame: 1 year ]
    Major bleeding (not related to coronary-artery bypass grafting, BARC 3-5)

  18. Need for renal replacement therapy [ Time Frame: 30 days ]
    Need for renal replacement therapy

  19. Quality of Life Seattle Angina Questionnaire [ Time Frame: 30 days ]
    Seattle Angina Questionnaire. Scale 1-5. Higher values represent better outcome

  20. Quality of life Seattle Angina Questionnaire [ Time Frame: 1 year ]
    Seattle Angina Questionnaire. Scale 1-5. Higher values represent better outcome

  21. Quality of Life EQ5D [ Time Frame: 30 days ]
    EQ5D EQ5D EQ5D. Scale 1-5. Higher values represent worse outcome

  22. Quality of life EQ5D [ Time Frame: 1 year ]
    EQ5D. Scale 1-5. Higher values represent worse outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion criteria STEMI-ACS ST-segment elevation myocardial infarction (STEMI) Both criteria must be present for eligibility

  • Chest pain for more than 20 minutes with an electrocardiographic ST-segment elevation of 1 mm or greater in two or more contiguous leads, or with a new left bundle-branch block
  • Admission either within 12 hours of symptom onset or between 12 and 24 hours after onset with evidence of continuing ischemia.

Inclusion criteria for NSTE-ACS Non-ST-segment elevation myocardial infarction (NSTEMI) At least two of the following must be present for eligibility

  • History consistent with new, or worsening ischemia, occurring at rest or with minimal activity
  • Coronary angiography with indication to PCI
  • Troponin T or I or creatine kinase MB above the upper limit of normal
  • Electrocardiographic changes compatible with ischemia but not diagnostic for ST-segment elevation myocardial infarction (i.e. ST depression of 1 mm or greater in two contiguous leads, T-wave inversion more than 3 mm, or any dynamic ST shifts) 0 Unstable Angina (UA)

At least two of the following must be present in the absence of cardiomyocyte necrosis (i.e. Troponin T or I and creatine kinase MB must be within normal limits):

  • History consistent with new, or worsening ischemia, occurring at rest or with minimal activity
  • Coronary angiography with indication to PCI
  • Electrocardiographic changes compatible with ischemia but not diagnostic for ST-segment elevation myocardial infarction (i.e. ST depression of 1 mm or greater in two contiguous leads, T-wave inversion more than 3 mm, or any dynamic ST shifts)

General inclusion criteria:

  • Age ≥ 18 years ≤ 85 years
  • The patient is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki
  • Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Instructions for Use' that comes with every Biotronik Orsiro (Sirolimus-Eluting stent) system.
  • The patient is willing and able to cooperate with study procedures and the required follow up visits
  • The subject or legal representative has been informed of the nature of the study and agrees to its provisions and has provided an EC approved written informed consent, including data privacy authorization

Exclusion Criteria:

  • Age <18 years and > 85 years
  • Single coronary vessel disease
  • Patients in cardiogenic shock
  • Patients who cannot give informed consent or have a life expectancy of less than 1year
  • Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to any of the study medications, including both aspirin and P2Y12 inhibitors.
  • Enrollment in another study with another investigational device or drug trial that has not reached the primary endpoint . The patient may only be enrolled once in the BioVAsc study
  • PCI in the previous 30 days.
  • Presence of a chronic total occlusion
  • Previous CABG
  • Women of childbearing potential who do not have a negative pregnancy test within 7 days before the procedure and women who are breastfeeding.
  • Planned surgery within 6 months after PCI, unless dual antiplatelet therapy is maintained throughout the peri-surgical period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03621501


Contacts
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Contact: Roberto Diletti, Dr. 0031107035046 r.diletti@erasmusmc.nl
Contact: Wijnand den Dekker, Dr. 0031107035029 w.dendekker@erasmusmc.nl

Locations
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Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Zuid Holland, Netherlands, 3015 GD
Contact: Roberto Diletti, MD, PhD    0031634767375    r.diletti@erasmusmc.nl   
Sponsors and Collaborators
Erasmus Medical Center
Biotronik SE & Co. KG
Investigators
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Study Chair: Nicolas van Mieghem, Dr Erasmus Medical Center

Publications of Results:
Quadri G, D'Ascenzo F, Moretti C, D'Amico M, Raposeiras-Roubín S, Abu-Assi E, Henriques JPS, Saucedo J, González-Juanatey JR, Wilton SB, Kikkert WJ, Nuñez-Gil I, Ariza-Sole A, Song X, Alexopoulos D, Liebetrau C, Kawaji T, Huczek Z, Nie SP, Fujii T, Correia L, Kawashiri MA, García-Acuña JM, Southern D, Alfonso E, Terol B, Garay A, Zhang D, Chen Y, Xanthopoulou I, Osman N, Möllmann H, Shiomi H, Omedè P, Montefusco A, Giordana F, Scarano S, Kowara M, Filipiak K, Wang X, Yan Y, Fan JY, Ikari Y, Nakahashi T, Sakata K, Yamagishi M, Kalpak O, Kedev S, Varbella F, Gaita F. Complete or incomplete coronary revascularisation in patients with myocardial infarction and multivessel disease: a propensity score analysis from the "real-life" BleeMACS (Bleeding complications in a Multicenter registry of patients discharged with diagnosis of Acute Coronary Syndrome) registry. EuroIntervention. 2017 Jul 20;13(4):407-414. doi: 10.4244/EIJ-D-16-00350.

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Responsible Party: Roberto Diletti, Dr., Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT03621501    
Other Study ID Numbers: BioVasc protocol definitive
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roberto Diletti, Erasmus Medical Center:
Percutaneous coronary intervention
Multivessel disease
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases