BIOFLOW-Dual Anti-Platelet Therapy

BIOTRONIK- A Prospective, Randomised, Multi-center Study to Assess the Safety of the Orsiro Mission Stent Compared to Resolute Onyx Stent in Subjects at High Risk of Bleeding in Combination With 1-month Dual Antiplatelet Therapy (DAPT)

Sponsors

Lead Sponsor: Chinese University of Hong Kong

Source Chinese University of Hong Kong
Brief Summary

BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomised controlled clinical study. A total of 1,948 subjects will be randomised 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.

Overall Status Recruiting
Start Date 2020-06-04
Completion Date 2024-09-01
Primary Completion Date 2024-06-28
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Rate of Major Adverse Cardiovascular Event (MACE) 12 months post-operation 12 months
Secondary Outcome
Measure Time Frame
Rate of stent thrombosis (ST) 12 months
Rate of Major Adverse Cerebral &Cardiovascular Event (MACCE) 12 months
Death rate 12 months
Rate of tricuspid valve replacement (TVR) 12 months
Rate of Revascularisation 12 months
rate of Target vessel failure 12 months
Rate of Target lesion failure 12 months
Rate of bleeding 12 months
Device success rate 12 months
Procedure success rate 12 months
Enrollment 50
Condition
Intervention

Intervention Type: Device

Intervention Name: Orsiro Mission

Description: Percutaneous intervention using Orsiro Mission stent

Arm Group Label: Orsiro

Intervention Type: Device

Intervention Name: Resolute Onyx

Description: Percutaneous intervention using Resolute Onyx stent

Arm Group Label: Resolute Onyx

Eligibility

Criteria:

Inclusion Criteria: - Subject is acceptable candidate for treatment with a DES - 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 30-59ml/min) or severe (estimated GFR <= 30ml/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 haemoglobin < 11.0 g/dL or requiring transfusion within 4 weeks prior to randomisation 6. baseline thrombocytopenia defined as a platelet count < 100,000/mm3. 7. History of stroke (ischemic or haemorrhagic), previous intracerebral hemorrhage (ICH) (spontaneous at any time or traumatic within the past 12 months) or presence of a brain arteriovenus malformation 8. history of hospitalisation for bleeding within the past 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. clinically indication for chronic or lifelong steroid or oral non-steroidal anti-inflammation drug(s) (NSAIDs), other than aspirin 12. Nondeferrable major surgery on DAPT 13. Recent major surgery or trauma within 30 days before PCI 14. PRECISE DAPT score >= 25 - Subject is >=18 years or the minimum age required for legal adult consent in the country of enrollment - Subject is capable ( no legally authorised 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. - Subject is willing to comply with all protocol and follow-up requirements, including agreement to discontinue DAPT at 1 month. - Subject is eligible for dual antiplatelet therapy treatment with aspiring plus a P2Y12 inhibitor agent for 1-month post index procedure Exclusion Criteria: - Subject who previously experienced a stent or scaffold thrombosis in any coronary vessel - 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 iridium, silicon carbide, PLLA, polymers, mTOR inhibiting drugs such as zotarolimus or sirolimus, or contrast media - Revascularisation of any target vessel within 9 months prior to the index procedure - Subject with documented left ventricular ejaculation 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. - Subject judged by physician as inappropriate for discontinuation from DAPT at 1 month following index procedure, due to another condition requiring chronic DAPT - 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 - Active bleeding at the time of inclusion - Subject with a current medical condition with a life expectancy of less than 12 months - Subject is currently participating or intends to participate in another investigational drug or device trial within 12 months following index procedure or any other clinical trial that may interfere with the treatment or protocol of this study - Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study - In the investigator' opinion, subject will not be able to comply with the follow-up requirements - Subjects who needs an impartial witness to give an informed consent

Gender:

All

Minimum Age:

75 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Bryan Yan Principal Investigator Chinese University of Hong Kong
Overall Contact

Last Name: Daniel Xu

Phone: 35051518

Email: [email protected]

Location
Facility: Status: Contact: The Chinese University of Hong Kong Daniel Xu 35051518 1518 [email protected]
Location Countries

Hong Kong

Verification Date

2022-09-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Chinese University of Hong Kong

Investigator Full Name: Professor Bryan Ping Yen YAN

Investigator Title: Professor

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Orsiro

Type: Experimental

Label: Resolute Onyx

Type: Active Comparator

Acronym BIOFLOW-DAPT
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

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