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History of Changes for Study: NCT04137510
C1703 BIOFLOW-DAPT
Latest version (submitted April 11, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 22, 2019 None (earliest Version on record)
2 October 23, 2019 Outcome Measures, Study Identification, Conditions and Study Status
3 February 27, 2020 Recruitment Status, Study Status, Contacts/Locations and Oversight
4 March 26, 2020 Contacts/Locations and Study Status
5 May 27, 2020 Study Status and Contacts/Locations
6 June 11, 2020 Study Status and Contacts/Locations
7 August 7, 2020 Contacts/Locations and Study Status
8 October 12, 2020 Study Status and Contacts/Locations
9 January 12, 2021 Contacts/Locations and Study Status
10 May 6, 2021 Study Status and Contacts/Locations
11 December 8, 2021 Recruitment Status, Contacts/Locations, Study Status and Study Design
12 February 14, 2023 Study Status, Eligibility, Outcome Measures, Study Design and Study Description
13 April 11, 2023 Study Status and Contacts/Locations
Comparison Format:
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Study NCT04137510
Submitted Date:  October 22, 2019 (v1)
Open or close this module Study Identification
Unique Protocol ID: C1703
Brief Title: C1703 BIOFLOW-DAPT
Official Title: BIOTRONIK - A Prospective, Randomized, Multi-center Study to Assess the SaFety of the Orsiro Mission Stent Compared to the ResoLute Onyx Stent in Subjects at High Risk for Bleeding in Combination With 1-month Dual Antiplatelet Therapy (DAPT)
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2019
Overall Status: Not yet recruiting
Study Start: March 1, 2020
Primary Completion: April 1, 2023 [Anticipated]
Study Completion: April 1, 2023 [Anticipated]
First Submitted: October 22, 2019
First Submitted that
Met QC Criteria:		 October 22, 2019
First Posted: October 24, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:		 October 22, 2019
Last Update Posted: October 24, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Biotronik AG
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study.

A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro or Resolute Onyx. After index procedure, all patients will receive DAPT (ASA + P2Y12 inhibitor) for 30 days, followed by monotherapy with either P2Y12 inhibitor or ASA only until the end of the study.

Clinical follow-up visits will be scheduled at 1, 6 and 12 months post-procedure.
Detailed Description:
Open or close this module Conditions
Conditions: Dual Antiplatelet Therapy Duration After Stent Implantation in Patients at High Risk for Bleeding
Keywords: DAPT
Dual antiplatelet therapy
high bleeding risk
HBR
Coronary artery disease
Percutaneous coronary intervention
PCI
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Prospective, multi-center, international, two-arm randomized controlled clinical study.
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 1948 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Orsiro Device: Percutaneous coronary intervention
It's a non-surgical procedure that uses a catheter to place a stent into a coronary blood vessel in order to open up the vessel.
Active Comparator: Resolute Onyx Device: Percutaneous coronary intervention
It's a non-surgical procedure that uses a catheter to place a stent into a coronary blood vessel in order to open up the vessel.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. cardiac death, myocardial infarction (MI) and definite or probable stent thrombosis at 12 months
[ Time Frame: 12 months post-procedure ]
Secondary Outcome Measures:
1. Rate of definite/probable stent thrombosis according to the ARC definition
[ Time Frame: until 12 months post-procedure ]
2. Rate of MACCE
[ Time Frame: until 12 months post-procedure ]

composite of all-cause death, MI, and stroke
3. MACE
[ Time Frame: until 12 months post-procedure ]

composite of cardiac death, MI, and Target Vessel Revascularization (TVR)
4. Rate of cardiac death or MI
[ Time Frame: until 12 months post-procedure ]

all, target vessel related MI, Q-wave and non Q-wave, ST-related and non ST-related
5. Rate of all-cause death, cardiac, non-cardiac
[ Time Frame: until 12 months post-procedure ]
6. Rate of stroke, ischemic and hemorrhagic
[ Time Frame: until 12 months post-procedure ]
7. Rate of clinically-indicated TVR
[ Time Frame: until 12 months post-procedure ]
8. Rate of clinically-indicated Target Lesion Revascularization (TLR)
[ Time Frame: until 12 months post-procedure ]
9. Rate of Target Vessel Failure (TVF)
[ Time Frame: until 12 months post-procedure ]

Composite of clinically-driven TVR, cardiac death or target-vessel related MI
10. Rate of target lesion failure (TLF)
[ Time Frame: until 12 months post-procedure ]

Composite of clinically driven TLR, cardiac death or target vessel related MI
11. Rate of bleeding according to BARC definition
[ Time Frame: until 12 months post-procedure ]
12. Rate of bleeding according to GUSTO definition
[ Time Frame: until 12 months post-procedure ]
13. Rate of bleeding according to TIMI definition
[ Time Frame: until 12 months post-procedure ]
14. Device success
[ Time Frame: until 12 months post-procedure ]

Attainment of less than 30% residual stenosis of the target lesion using assigned stent only
15. Procedure success
[ Time Frame: until 12 months post-procedure ]

Attainment of less than 30% residual stenosis of the target lesion using assigned stent only without occurrence of in-hospital major adverse cardiac events
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Subject is acceptable candidate for treatment with a DES
  2. Subject is considered at high bleeding risk (HBR), defined as meeting one or more of the following criteria at the time of enrollment:
    1. ≥ 75 years of age
    2. Moderate (estimated GFR 30-59 ml/min) or severe (estimated GFR < 30 ml/min) chronic kidney disease or failure (dialysis dependent)
    3. Advanced liver disease, defined as having cirrhosis with or without portal hypertension and with or without gastroesophageal varices.
    4. Cancer (excluding non-melanoma skin cancer) diagnosed or treated within the previous 12 months or actively treated
    5. Anemia with hemoglobin < 11.0 g/dL or requiring transfusion within 4 weeks prior to randomization
    6. Baseline thrombocytopenia defined as a platelet count <100,000/mm3
    7. History of stroke (ischemic or hemorrhagic), or brain arteriovenous malformation
    8. History of hospitalization for bleeding within the previous 12 months
    9. Chronic clinically significant bleeding diathesis
    10. Clinical indication for chronic or lifelong oral anticoagulation (OAC) (with a vitamin K antagonist or non-vitamin K OAC)
    11. Clinical indication for chronic or lifelong steroid or oral nonsteroidal anti-inflammatory drug(s) (NSAIDs), other than aspirin
    12. Nondeferrable major surgery on DAPT
    13. Recent major surgery or major trauma within 30 days before PCI
    14. Precise DAPT score ≥ 25
  3. Subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrollment
  4. Subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure
  5. Subject is willing to comply with all protocol and follow-up requirements, including agreement to discontinue DAPT at 1 month
  6. Subject is eligible for dual antiplatelet therapy treatment with aspirin plus a P2Y12 inhibitor agent for 1-month post index procedure

Exclusion Criteria:

  1. Subject who previously experienced a stent or scaffold thrombosis in any coronary vessel
  2. Subject has a known allergy to all types of P2Y12 inhibitor (Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine and Cangrelor; thus preventing the use of the appropriate P2Y12 inhibitor), aspirin, both heparin and bivalirubin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), silicon carbide, PLLA, Sirolimus, or contrast media
  3. Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 72 hours prior to or during the index procedure
  4. Subject with documented left ventricular ejection fraction (LVEF) <30% as evaluated by the most recent imaging exam (i.e. echocardiogram, ventriculogram, MUGA, etc.)
  5. Subject judged by physician as inappropriate for discontinuation from DAPT at 1 month following index procedure, due to another condition requiring chronic DAPT
  6. Subject with planned surgery or procedure necessitating discontinuation of P2Y12 inhibitor and/or aspirin within the first month post-index procedure Note - planned staged procedure at the time of index procedure is not allowed
  7. Active bleeding at the time of inclusion
  8. Subject with a current medical condition with a life expectancy of less than 12 months
  9. Subject is currently participating or intends to participate in another investigational drug or device trial within 12 months following the index procedure or any other clinical trial that may interfere with the treatment or protocol of this study
  10. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study
  11. In the investigator's opinion, subject will not be able to comply with the follow-up requirements
Open or close this module Contacts/Locations
Central Contact Person: Olga Neklyudova, PhD
Telephone: +41 44 864 51 87
Email: olga.neklyudova@biotronik.com
Central Contact Backup: Barbara Galeuchet-Schenk, PhD
Telephone: +41 44 864 53 59
Email: barbara.galeuchet-schenk@biotronik.com
Study Officials: Marco Valgimigli, Prof. Dr.
Principal Investigator
Center for Structural Heart Disease, University Hospital for Cardiology, Inselspital Bern
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services