Bioflow-DAPT Study

Coronary Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04137510
• Other study ID #: C1703
• Status: Completed
• Phase: Phase 4
• Start date: February 24, 2020
• Est. completion date: September 20, 2022

Study information

• Verified date: April 2023
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Mission 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1948
• Est. completion date: September 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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), previous intracerebral hemorrhage (ICH) (spontaneous at any time or traumatic within the past 12 months) or presence of a 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 bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten, nickel), molybdenum, platinum and irridium, silicon carbide, PLLA,polymers, mTOR inhibiting drugs such as zotarolimus or 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. 4. Subject with documented left ventricular ejection fraction (LVEF) <30% as evaluated by the most recent imaging exam (i.e. echocardiogram, ventriculogram, MUGA, etc.), but within 90 days pre/procedure or during the index procedure

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

12. Subjects who need an impartial witness to give an informed consent

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Australia	The Northern Hospital	Epping
Australia	John Hunter Hospital	New Lambton
Australia	Royal Perth Hospital	Perth
Austria	Medizinische Universität Graz	Graz
Austria	Uniklinikum Salzburg	Salzburg
Belgium	AZ St Jan Brugge	Brugge
Belgium	Ziekenhuis Oost Limburg Genk	Genk
Belgium	AZ Delta	Roeselare
Belgium	UCL St Luc	Woluwe-Saint-Lambert
Denmark	Herlev og Gentofte Hospital	Hellerup
Denmark	Roskilde University Hospital	Roskilde
France	CHU Brest	Brest
France	Centre Hospitalier Universitaire de Lille	Lille
France	Hopital Privé Jacques Cartier	Massy
France	CHU Nimes	Nîmes
France	Assistance Publique Hopitaux de Paris	Paris
France	Assistance Publique Hopitaux de Paris (APHP)	Paris
France	Clinique Saint Hilaire	Rouen
France	CHU de Toulouse	Toulouse
France	Clinique Pasteur	Toulouse
France	CHRU de Tours	Tours
Germany	Segeberger Kliniken	Bad Segeberg
Germany	Charite Virchow-Klinikum	Berlin
Germany	Contilla Herz- und Gefäßzentrum, Elisabeth-Krankenhaus	Essen
Germany	Klinikum Friedrichshafen GmbH	Friedrichshafen
Germany	Städtische Kliniken Neuss, Lukaskrankenhaus GmbH	Neuss
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	The Chinese University of Hong Kong	Shatin
Hungary	Semmelweis University	Budapest
Hungary	Somogy County Kaposi Mór Teaching Hospital	Kaposvár
Hungary	University of Pécs	Pécs
Italy	Azienda Ospedaliero - Universitaria Policlinico - Vittorio	Catania
Italy	Centro Cardiologico Monzino	Milano
Italy	IRCCS Fondazione Policlinico "San Matteo"	Pavia
Italy	Azienda Ospedaliero-Universitaria	Torrette
Latvia	Sia AK Medical Solutions	Engure
Latvia	Pauls Stradins Clinical University Hospital	Riga
Malaysia	Institut Jantung Negara	Kuala Lumpur
Netherlands	Haga Ziekenhuis	Den Haag
New Zealand	Auckland City Hospital	Auckland
Poland	Krakowski Szpital Specjalistyczny im. Jana Pawla	Krakow
Poland	Miedziowe Centrum Zdrowia	Lubin
Singapore	Tan Tock Seng Hospital	Singapore
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Clinico Universitario de la Valencia	Valencia
Spain	Hospital Universitario Araba	Vitoria
Switzerland	Hôpitaux Universitaires de Genève	Genève
Switzerland	Centre Hospitalier Universitaires Vaudoise	Lausanne
Switzerland	CardioCentro Ticino	Lugano
Switzerland	Hôpital de Morges	Morges
Switzerland	Stadtspital Triemli	Zürich
Thailand	Central Chest Institute of Thailand	Bangkok
Thailand	Phramongkutklao Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Denmark,  France,  Germany,  Hong Kong,  Hungary,  Italy,  Latvia,  Malaysia,  Netherlands,  New Zealand,  Poland,  Singapore,  Spain,  Switzerland,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of cardiac death, myocardial infarction (MI) and definite or probable stent thrombosis at 12 months		12 months post-procedure
Secondary	Rate of definite/probable stent thrombosis according to the ARC definition		until 12 months post-procedure
Secondary	Rate of MACCE	composite of all-cause death, MI, and stroke	until 12 months post-procedure
Secondary	Rate of MACE	composite of cardiac death, MI, and Target Vessel Revascularization (TVR)	until 12 months post-procedure
Secondary	Rate of cardiac death or MI	all, target vessel related MI, Q-wave and non Q-wave, ST-related and non ST-related	until 12 months post-procedure
Secondary	Rate of all-cause death, cardiac, non-cardiac		until 12 months post-procedure
Secondary	Rate of stroke, ischemic and hemorrhagic		until 12 months post-procedure
Secondary	Rate of clinically-indicated TVR		until 12 months post-procedure
Secondary	Rate of clinically-indicated Target Lesion Revascularization (TLR)		until 12 months post-procedure
Secondary	Rate of Target Vessel Failure (TVF)	Composite of clinically-driven TVR, cardiac death or target-vessel related MI	until 12 months post-procedure
Secondary	Rate of target lesion failure (TLF)	Composite of clinically driven TLR, cardiac death or target vessel related MI	until 12 months post-procedure
Secondary	Rate of bleeding according to BARC definition		until 12 months post-procedure
Secondary	Rate of bleeding according to GUSTO definition		until 12 months post-procedure
Secondary	Rate of bleeding according to TIMI definition		until 12 months post-procedure
Secondary	Rate of Device success	Attainment of less than 30% residual stenosis of the target lesion using assigned stent only	until 12 months post-procedure
Secondary	Rate of Procedure success	Attainment of less than 30% residual stenosis of the target lesion using assigned stent only without occurrence of in-hospital major adverse cardiac events	until 12 months post-procedure