Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus Resolute Integrity conducted in approximately 14 interventional cardiology centers in The Netherlands, Belgium, Spain and Portugal. Clinical follow-up will occur at 1, 9 and 12 months post-stent implantation. All patients will undergo repeat angiography at 9 months follow-up. QCA assessment will be performed at baseline (pre- and post-procedure) and at 9 months follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
168
Imelda Hospital
Bonheiden, Belgium
CHU Chaleroi
Chaleroi, Belgium
Oost-limburg Hospital
Genk, Belgium
AMC
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
UMCG
Groningen, Netherlands
Maasstad Hospital
Rotterdam, Netherlands
Hospita; Garcia de Orta
Almada, Portugal
Santa Maria University Hospital
Lisbon, Portugal
Gaia/Espinho Hospital Centers
Porto, Portugal
...and 2 more locations
Late Lumen Loss
The primary endpoint is in-stent Late Lumen Loss (LLL) at 9 months after stent implantation as assessed by off-line QCA.
Time frame: Up to 9 month
Angiographic endpoint
Acute Lumen Gain (mm);
Time frame: 9 and 12 month
Angiographic endpoint
MLD (mm) post procedure and at 9 months;
Time frame: 9 and 12 month
Angiographic endpoint
Diameter Stenosis (%) post procedure and at 9 months;
Time frame: 9 and 12 month
Angiographic endpoint
Binary Restenosis (DS ≥50%) at 9 months
Time frame: 9 and 12 month
Clinical endpoint
Acute success (device and procedural success)
Time frame: 9 and 12 month
Cinical endpoint
Device-oriented Composite Endpoints (DoCE) at 1, 9 and 12 months and its individual components. (Device-oriented Composite Endpoint is defined as Cardiac Death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated Target Lesion Revascularization).
Time frame: 9 and 12 month
Clinical endpoint
Myocardial infarction (Q-wave, Non q-wave) at all time points.
Time frame: 9 and 12 month
Clinical endpoint
Any revascularization at all time points.
Time frame: 9 and 12 month
Clinical endpoint
Stent thrombosis according to the ARC definitions up to 12 months follow-up.
Time frame: 9 and 12 month
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