Clinical trial NCT03260517: The PREVAIL Study
Official title: A Clinical PeRformance EVAluatIon of a New Medtronic Coronary Drug-Coated BaLloon Catheter for the Treatment of De Novo Lesions, In-Stent Restenosis and Small Vessel Disease in Coronary Arteries: The PREVAIL Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: In-stent Restenosis
Ischemic Heart Disease
Coronary Artery Disease
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2017-08-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.

Detailed description: This study is a prospective, pre-market, multi-center, single arm study evaluating up to 50 subjects with symptoms of ischemic heart disease attributable to stenotic lesions of the coronary arteries that are amenable to treatment with the Medtronic Coronary Drug-Coated Balloon Catheter.

Patients with de novo lesions, In-Stent Restenosis or small vessel disease who qualify for percutaneous coronary interventions treatable with the device with a diameter between 2.0 mm to 4.0 mm and a length ≤25 mm will be screened and are intended to participate in this study.

Each subject is expected to be followed in the study for 12 months. Procedural/acute outcomes and clinical outcomes will be assessed at procedure, 30 days, 6 and 12 months.

Eligibility criteria: Key Inclusion Criteria

* Subject with documented stable or unstable angina, and/or clinical evidence of ischemia
* Subject is an acceptable candidate for treatment with a Coronary Drug- Coated Balloon in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki.

Key Exclusion Criteria

* Acute Myocardial Infarction within the previous 72 hours
* Planned treatment involves a bifurcation
* Three vessel disease

Primary outcomes:
measure: In-stent (in balloon) Late Lumen Loss (LLL) as measured by Quantitative coronary angiography (QCA) at six months
timeFrame: At 6 months follow up
Secondary outcomes:
measure: All deaths including cardiac death.procedure
timeFrame: 30 days, 6 months and 1 year after procedure
measure: Target Vessel Myocardial Infarction (TVMI)
timeFrame: 30 days, 6 months and 1 year after procedure
measure: Major adverse cardiac event (MACE) defined as composite of death, Myocardial infarction (MI), emergent Coronary Artery Bypass Graft (CABG) or repeat Target lesion revascularization (TLR) (clinically driven) by percutaneous or surgical methods
timeFrame: 30 days, 6 months and 1 year after procedure
measure: Target vessel failure (TVF) defined as cardiac death, TVMI, or clinically-driven Target vessel revascularization (TVR) by percutaneous or surgical methods.
timeFrame: 30 days, 6 months and 1 year after procedure
measure: 5. Target lesion failure (TLF) defined by a composite of cardiac death, TVMI, or clinically-driven TLR by percutaneous or surgical methods.
timeFrame: 30 days, 6 months and 1 year after procedure
measure: All revascularizations (TLR, TVR and non-TVR).
timeFrame: 30 days, 6 months and 1 year after procedure
measure: Stent Thrombosis rate as defined as definite, probable, possible, and overall stent thrombosis (according to Academic Research Consortium definition).
timeFrame: 30 days, 6 months and 1 year after procedure
measure: Acute success (device, lesion and procedure success).
timeFrame: 30 days, 6 months and 1 year after procedure
Other outcomes:
measure: In-stent (balloon) and in-segment LLL
timeFrame: 6 months post-procedure
measure: In-stent (balloon) and in-segment percent diameter stenosis (%DS (Percent diameter stenosis)).
timeFrame: 6 months post-procedure
measure: In-stent (balloon) and in-segment Binary Angiographic Restenosis (BAR) rate [defined as ≥50% diameter stenosis (DS)].
timeFrame: 6 months post-procedure
measure: In-stent (balloon) and in-segment Minimum luminal/lumen diameter (MLD).
timeFrame: 6 months post-procedure
Locations:
city: Antwerp
country: Belgium
facility: ZNA Middelheim
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Liège
country: Belgium
facility: CHU Liege
city: Milano
country: Italy
facility: IRCCS Policlinico San Donato
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis locatie Leyweg
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Zwolle
country: Netherlands
facility: Isala Klinieken
Study officials:
References:
citation: Grosso A, Neves de Faria RI, Bojke L, Donohue C, Fraser CI, Harron KL, Oddie SJ, Gilbert R. Cost-effectiveness of strategies preventing late-onset infection in preterm infants. Arch Dis Child. 2020 May;105(5):452-457. doi: 10.1136/archdischild-2019-317640. Epub 2019 Dec 13.