The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration (1…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the clinical safety of the Resolute Onyx stent as compared to the
BioFreedom stent with use of 1month DAPT in subjects deemed at high risk for
bleeding and/or medically unsuitable for more than 1 month DAPT treatment.
Secondary outcome
To evaluate the clinical effectiveness of the Resolute Onyx stent as compared
to the BioFreedom stent with use of 1 month DAPT in subjects deemed at high
risk for bleeding and/or medically unsuitable for more than 1 month DAPT
treatment.
Background summary
See protocol section 3.0 for more information in depth.
Both ESC and ACC guidelines acknowledge that there is limited clinical evidence
of dedicated DAPT studies in HBR patients, especially with existing stents.
Therefore, there is a strong need for randomized trials that evaluate the
optimal DAPT duration in HBR patients undergoing implantation of current
generation DES
Study objective
The purpose of this study is to evaluate the clinical safety and effectiveness
of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or
medically unsuitable for more than 1 month DAPT treatment receiving reduced
duration (1 month) of DAPT following stent implantation
Study design
The Onyx ONE Study is a prospective, multi-center, blinded, post-market
interventional, randomized, controlled study enrolling eligible subjects at
qualified centers worldwide. The enrollment period is anticipated to be
approximately 14 months. Subjects will remain in the study with follow-up
clinical assessments through 2 years, study exit, or death, whichever comes
first. The population will consist of subjects with coronary artery disease
undergoing stent implantation with one of the following commercially available
stents and Dual Anti-platelet Therapy through one month: Resolute Onyx (Drug
eluting stent, Medtronic) or BioFreedom (Drug coated stent, Biosensors
International)
Intervention
Screening and implant (index)PCI procedure;
Subjects will be randomized at a 1:1 ratio to treatment with Resolute Onyx
stent or the BioFreedom stent (control).
Clinic visit health status assessment:
* 1 month Subject contact health status assessments (the subject will be
assessed by telephone, e-mail, or office visit):
* 2 months
* 6 months
* 1 year
* 2 years
Angiography should be performed for any post-procedure clinical event (e.g.,
MI) to determine if the event is attributable to the target vessel or a
non-target vessel. The reason for any repeat angiography (either clinically
driven or non-clinically driven) must be documented on the electronic case
report form (eCRF)
Study burden and risks
The potential risks do not differ from the risks associated with the
conventional/routine PCI DES implantation procedures described in the Dutch
heart foundation.
Endepolsdomein 5
Maastricht 6229 GW
NL
Endepolsdomein 5
Maastricht 6229 GW
NL
Listed location countries
Age
Inclusion criteria
All subjects who are acceptable candidates for treatment with a DES in
accordance with applicable guidelines for percutaneous coronary interventions,
per manufacturer*s Instructions for Use (and for Australia per IB) who
additionally meet pre-defined criteria for being high-bleeding risk and are
candidates for 1-month DAPT
To qualify as high-bleeding risk and/or a candidate for 1-month DAPT, subject
must meet at least one of the following criteria, -Adjunctive oral
anticoagulation treatment planned to continue after PCI
* Age * 75 years old * Baseline Hgb <11 g/dl (or anemia requiring transfusion
during the 4 weeks prior to randomization) * Any prior documented intracerebral
bleed
* Any documented stroke in the last 12 months
* Hospital admission for bleeding during the prior 12 months
* Non-skin cancer diagnosed or treated *3 years * Planned daily NSAID (other
than aspirin) or steroids for *30 days after PCI
* Planned surgery that would require interruption of DAPT (within the next 12
months)
* Renal failure defined as: Creatinine clearance <40 ml/min
* Thrombocytopenia (PLT <100,000/mm3)
* Severe chronic liver disease defined as: subjects who have developed any of
the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
* Expected non-compliance to prolonged DAPT for other medical reasons
Exclusion criteria
* Subjects requiring a planned PCI procedure after one month of index procedure
* Subject with planned surgery or procedure necessitating discontinuation of
DAPT within one month following index procedure
* Subject not expected to comply with long-term single antiplatelet therapy.
* Subjects with life expectancy of less than two years
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03344653 |
| CCMO | NL63642.075.17 |