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Bioflow-DAPT Study

Sponsor
Biotronik AG (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04137510
Collaborator
(none)
1,949
Enrollment
52
Locations
2
Arms
37.2
Anticipated Duration (Months)
37.5
Patients Per Site
1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Percutaneous coronary intervention
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
1949 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective, multi-center, international, two-arm randomized controlled clinical study.Prospective, multi-center, international, two-arm randomized controlled clinical study.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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)
Actual Study Start Date :
Feb 24, 2020
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Rate of cardiac death, myocardial infarction (MI) and definite or probable stent thrombosis at 12 months [12 months post-procedure]

Secondary Outcome Measures

  1. Rate of definite/probable stent thrombosis according to the ARC definition [until 12 months post-procedure]

  2. Rate of MACCE [until 12 months post-procedure]

    composite of all-cause death, MI, and stroke

  3. Rate of MACE [until 12 months post-procedure]

    composite of cardiac death, MI, and Target Vessel Revascularization (TVR)

  4. Rate of cardiac death or MI [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 [until 12 months post-procedure]

  6. Rate of stroke, ischemic and hemorrhagic [until 12 months post-procedure]

  7. Rate of clinically-indicated TVR [until 12 months post-procedure]

  8. Rate of clinically-indicated Target Lesion Revascularization (TLR) [until 12 months post-procedure]

  9. Rate of Target Vessel Failure (TVF) [until 12 months post-procedure]

    Composite of clinically-driven TVR, cardiac death or target-vessel related MI

  10. Rate of target lesion failure (TLF) [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 [until 12 months post-procedure]

  12. Rate of bleeding according to GUSTO definition [until 12 months post-procedure]

  13. Rate of bleeding according to TIMI definition [until 12 months post-procedure]

  14. Rate of Device success [until 12 months post-procedure]

    Attainment of less than 30% residual stenosis of the target lesion using assigned stent only

  15. Rate of Procedure success [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  3. ≥ 75 years of age

  4. Moderate (estimated GFR 30-59 ml/min) or severe (estimated GFR < 30 ml/min) chronic kidney disease or failure (dialysis dependent)

  5. Advanced liver disease, defined as having cirrhosis with or without portal hypertension and with or without gastroesophageal varices.

  6. Cancer (excluding non-melanoma skin cancer) diagnosed or treated within the previous 12 months or actively treated

  7. Anemia with hemoglobin < 11.0 g/dL or requiring transfusion within 4 weeks prior to randomization

  8. Baseline thrombocytopenia defined as a platelet count <100,000/mm3

  9. History of stroke (ischemic or hemorrhagic), or brain arteriovenous malformation

  10. History of hospitalization for bleeding within the previous 12 months

  11. Chronic clinically significant bleeding diathesis

  12. Clinical indication for chronic or lifelong oral anticoagulation (OAC) (with a vitamin K antagonist or non-vitamin K OAC)

  13. Clinical indication for chronic or lifelong steroid or oral nonsteroidal anti-inflammatory drug(s) (NSAIDs), other than aspirin

  14. Nondeferrable major surgery on DAPT

  15. Recent major surgery or major trauma within 30 days before PCI

  16. Precise DAPT score ≥ 25

  17. Subject is ≥ 18 years or the minimum age required for legal adult consent in the country of enrollment

  18. 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

  19. Subject is willing to comply with all protocol and follow-up requirements, including agreement to discontinue DAPT at 1 month

  20. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Northern Hospital Epping Australia 3076
2 John Hunter Hospital New Lambton Australia 2305
3 Royal Perth Hospital Perth Australia 6000
4 Medizinische Universität Graz Graz Austria 8036
5 Uniklinikum Salzburg Salzburg Austria 5020
6 AZ St Jan Brugge Brugge Belgium 8000
7 Ziekenhuis Oost Limburg Genk Genk Belgium 3600
8 AZ Delta Roeselare Belgium 8800
9 UCL St Luc Woluwe-Saint-Lambert Belgium 1200
10 Herlev og Gentofte Hospital Hellerup Denmark 2900
11 Roskilde University Hospital Roskilde Denmark 4000
12 CHU Brest Brest France 29601
13 Centre Hospitalier Universitaire de Lille Lille France 59000
14 Hopital Privé Jacques Cartier Massy France 91300
15 CHU Nimes Nîmes France 30029
16 Assistance Publique Hopitaux de Paris (APHP) Paris France 75004
17 Assistance Publique Hopitaux de Paris Paris France 75004
18 Clinique Saint Hilaire Rouen France 76000
19 Clinique Pasteur Toulouse France 31076
20 CHU de Toulouse Toulouse France 31400
21 Segeberger Kliniken Bad Segeberg Germany 23795
22 Charite Virchow-Klinikum Berlin Germany 13353
23 Contilla Herz- und Gefäßzentrum, Elisabeth-Krankenhaus Essen Germany 45138
24 Klinikum Friedrichshafen GmbH Friedrichshafen Germany 88048
25 Städtische Kliniken Neuss, Lukaskrankenhaus GmbH Neuss Germany 41464
26 Queen Mary Hospital Hong Kong Hong Kong
27 The Chinese University of Hong Kong Shatin Hong Kong
28 Semmelweis University Budapest Hungary 1124
29 Somogy County Kaposi Mór Teaching Hospital Kaposvár Hungary 7400
30 University of Pécs Pécs Hungary 7624
31 Azienda Ospedaliero - Universitaria Policlinico - Vittorio Catania Italy 95125
32 Centro Cardiologico Monzino Milano Italy 20138
33 IRCCS Fondazione Policlinico "San Matteo" Pavia Italy 27100
34 Azienda Ospedaliero-Universitaria Torrette Italy 60126
35 Sia AK Medical Solutions Engure Latvia LV-3113
36 Pauls Stradins Clinical University Hospital Riga Latvia 1002
37 Institut Jantung Negara Kuala Lumpur Malaysia 50400
38 Haga Ziekenhuis Den Haag Netherlands 2545 AA
39 Auckland City Hospital Auckland New Zealand 1142
40 Krakowski Szpital Specjalistyczny im. Jana Pawla Krakow Poland 31-202
41 Miedziowe Centrum Zdrowia Lubin Poland 59-301
42 Tan Tock Seng Hospital Singapore Singapore 308433
43 Hospital Universitario Marqués de Valdecilla Santander Spain 39008
44 Hospital Clinico Universitario de la Valencia Valencia Spain 46010
45 Hospital Universitario Araba Vitoria Spain 01009
46 Hôpitaux Universitaires de Genève Genève Switzerland 1211
47 Centre Hospitalier Universitaires Vaudoise Lausanne Switzerland 1011
48 CardioCentro Ticino Lugano Switzerland 6900
49 Hôpital de Morges Morges Switzerland 1110
50 Stadtspital Triemli Zürich Switzerland 8063
51 Phramongkutklao Hospital Bangkok Thailand 10400
52 Central Chest Institute of Thailand Bangkok Thailand 11000

Sponsors and Collaborators

  • Biotronik AG

Investigators

  • Principal Investigator: Marco Valgimigli, Prof. Dr., Cardiocentro Ticino, Via Tesserete 48, 6900 Lugano, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biotronik AG
ClinicalTrials.gov Identifier:
NCT04137510
Other Study ID Numbers:
  • C1703
First Posted:
Oct 24, 2019
Last Update Posted:
Dec 9, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Biotronik AG
DAPT
Dual antiplatelet therapy
high bleeding risk
HBR
Coronary artery disease
Percutaneous coronary intervention
PCI
Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease

Study Results

No Results Posted as of Dec 9, 2021