Clinical trial NCT02512003: Pilot Study of the Fantom Bioresorbable Scaffold (FANTOM I)
Official title: Pilot Study of the REVA 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: 2015-07-30
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The FANTOM I pilot study is intended to assess safety 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
* Patient has a normal CK-MB
* 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 ≥ 2.7mm and ≤ 3.3mm
* Target lesion length must be ≤ 14mm

Exclusion Criteria:

* Patient has experienced a myocardial infarction (CK-MB or Troponin \> 5 X ULN) within 72 hours of the procedure
* Patient has a left ventricular ejection fraction \< 25%
* Patient has unprotected lest 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 ≥ 2.0 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: Ischemia-driven Target Lesion Revascularization (TLR)
timeFrame: 4 months
Secondary outcomes:
measure: Quantitative Coronary Angiography (QCA) derived parameters
timeFrame: 4 months
measure: Quantitative Coronary Angiography (QCA) derived parameters
timeFrame: 4 months
measure: Quantitative Coronary Angiography (QCA) derived parameters
timeFrame: 4 months
measure: Quantitative Coronary Angiography (QCA) derived parameters
timeFrame: 4 months
measure: Quantitative Coronary Angiography (QCA) derived parameters
timeFrame: 4 months
measure: Intravascular Ultrasound (IVUS) derived parameters
timeFrame: 4 months
measure: Intravascular Ultrasound (IVUS) derived parameters
timeFrame: 4 months
measure: Intravascular Ultrasound (IVUS) derived parameters
timeFrame: 4 months
measure: Intravascular Ultrasound (IVUS) derived parameters
timeFrame: 4 months
measure: Intravascular Ultrasound (IVUS) derived parameters
timeFrame: 4 months
measure: Major Adverse Cardiac Events
timeFrame: 12, 24, 36, 48 and 60 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 12, 24, 36, 48 and 60 months
measure: Target Vessel Revascularization
timeFrame: 12, 24, 36, 48 and 60 months
measure: Target Vessel Failure (TVF)
timeFrame: 12, 24, 36, 48 and 60 months
measure: Acute Technical Success
timeFrame: Day 0
measure: Procedural Success
timeFrame: 30 days
measure: Optical Coherence Tomography (OCT) Imaging on a Subset of Patients
timeFrame: 4 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
city: Warszawa
country: Poland
facility: Pracownia Kardiologii Inwazyjnej I Katedry i Kliniki Kardiologii WUM
Study officials:
References: