Clinical trial NCT02539966: Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
Official title: Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: REVA Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-03
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.


Eligibility criteria: Inclusion Criteria:

* Patient has evidence of myocardial ischemia or a positive functional study
* Target lesion has a visually estimated stenosis of ≥50% and \<100%
* Target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.5mm and ≤ 3.5mm
* Lesion length ≤ 20 mm by visual estimate (N/A for Cohort C)
* Baseline TIMI flow ≥ 2

Exclusion Criteria:

* The patient has experienced an acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of the procedure and either CK-MB or Troponin has not returned to within 2X ULN.
* Patient has a left ventricular ejection fraction \< 40%
* Patient has unprotected left main coronary disease with ≥50% stenosis
* The target vessel is totally occluded (TIMI Flow 0 or 1)
* Target lesion involves a bifurcation (a lesion with a side branch ≥ 1.5 mm in diameter containing a ≥ 50% stenosis).
* Target lesion is located within a bypass graft
* Target lesion has possible or definite thrombus

Primary outcomes:
measure: Major Adverse Cardiac Events (MACE) - Cohorts A, B and C
timeFrame: 6 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
timeFrame: 6 months
Secondary outcomes:
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
timeFrame: 9 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
timeFrame: 6 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
timeFrame: 9 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
timeFrame: 6 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
timeFrame: 9 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
timeFrame: 6 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
timeFrame: 9 months
measure: Major Adverse Cardiac Events (MACE) - Cohorts A, B and C
timeFrame: 12, 24, 36, 48 and 60 months
measure: Target Lesion Revascularization (TLR) - Cohorts A, B and C
timeFrame: 12, 24, 36, 48 and 60 months
measure: Target Vessel Revascularization (TVR) - Cohorts A, B and C
timeFrame: 12, 24, 36, 48 and 60 months
measure: Target Vessel Failure (TVF) - Cohorts A, B and C
timeFrame: 12, 24, 36, 48 and 60 months
measure: Acute Technical Success - Cohorts A, B and C
timeFrame: Day 0
measure: Procedural Success - Cohorts A, B and C
timeFrame: 30 days
Other outcomes:
Locations:
city: Chermside
country: Australia
facility: The Prince Charles Hospital
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
city: Randwick
country: Australia
facility: Prince of Wales Hospital (Eastern Heart)
city: Aalst
country: Belgium
facility: Cardiovascular Center Aalst
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
city: São Paulo
country: Brazil
facility: Albert Einstein Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital (Skejby)
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
city: Massy
country: France
facility: institut Hospitalier J.Cartier
city: Paris
country: France
facility: La Pitié-Salpétrière
city: Toulouse
country: France
facility: Clinique Pasteur
city: Toulouse
country: France
facility: Hôpital Rangueil
city: Berlin
country: Germany
facility: Am Urban Hospital, Berlin
city: Berlin
country: Germany
facility: Friedrichshein Hospital, Berlin
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Dortmund
country: Germany
facility: St.- Johannes-Hospital Dortmund
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Amsterdam
country: Netherlands
facility: Academic Medical Center Amsterdam
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Krakow
country: Poland
facility: Krakowskie Centrum Kardiologii Inwazyjnej
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Poznan
country: Poland
facility: Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
city: Warszawa
country: Poland
facility: Oddział Kardiologii Inwazyjnej I Katedra
Study officials:
affiliation: Instituto Dante Pazzanese de Cardiologia
name: Alexandre Abizaid, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Elisabeth-Krankenhaus Essen
name: Christoph K Naber, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chevalier B, Abizaid A, Carrie D, Frey N, Lutz M, Weber-Albers J, Dudek D, Weng SC, Akodad M, Anderson J, Stone GW. Clinical and Angiographic Outcomes With a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold. Circ Cardiovasc Interv. 2019 Jun;12(6):e007283. doi: 10.1161/CIRCINTERVENTIONS.118.007283. Epub 2019 Jun 10.