Pilot Study of the Fantom Bioresorbable Scaffold (FANTOM I)

Coronary Artery Disease Clinical Trial

— FANTOM I  

Official title:

Pilot Study of the REVA Sirolimus-Eluting Bioresorbable Coronary Scaffold

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512003
• Other study ID #: HCT6000
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: April 2020

Study information

• Verified date: March 2023
• Source: REVA Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The FANTOM I pilot study is intended to assess safety of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 2020
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Fantom Scaffold

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese de Cardiologia	Sao Paulo
Poland	Pracownia Kardiologii Inwazyjnej I Katedry i Kliniki Kardiologii WUM	Warszawa

Sponsors (1)

Lead Sponsor	Collaborator
REVA Medical, Inc.

Countries where clinical trial is conducted

Brazil,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemia-driven Target Lesion Revascularization (TLR)	Percent of Patients with TLR at 4 months	4 months
Secondary	Quantitative Coronary Angiography (QCA) derived parameters	Late Loss	4 months
Secondary	Quantitative Coronary Angiography (QCA) derived parameters	Restenosis Rate	4 months
Secondary	Quantitative Coronary Angiography (QCA) derived parameters	% Diameter Stenosis	4 months
Secondary	Quantitative Coronary Angiography (QCA) derived parameters	Minimum Lumen Diameter	4 months
Secondary	Quantitative Coronary Angiography (QCA) derived parameters	Neointimal Volume	4 months
Secondary	Intravascular Ultrasound (IVUS) derived parameters	Late Loss	4 months
Secondary	Intravascular Ultrasound (IVUS) derived parameters	Restenosis Rate	4 months
Secondary	Intravascular Ultrasound (IVUS) derived parameters	% Diameter Stenosis	4 months
Secondary	Intravascular Ultrasound (IVUS) derived parameters	Minimum Lumen Diameter	4 months
Secondary	Intravascular Ultrasound (IVUS) derived parameters	Neointimal Volume	4 months
Secondary	Major Adverse Cardiac Events	Death, Q-Wave Myocardial Infarction, Non Q-Wave Myocardial Infarction (CK-MB > 5x normal), Target Vessel Revascularization	12, 24, 36, 48 and 60 months
Secondary	Target Lesion Revascularization (TLR)	Percentage of patients with TLR at each time point	12, 24, 36, 48 and 60 months
Secondary	Target Vessel Revascularization	Percentage of patients with TVR at each time point	12, 24, 36, 48 and 60 months
Secondary	Target Vessel Failure (TVF)	Percentage of patients with TVF at each time point	12, 24, 36, 48 and 60 months
Secondary	Acute Technical Success	Percentage of patients with successful acute delivery and deployment of the device	Day 0
Secondary	Procedural Success	Percentage of patients with angiographic success (final diameter stenosis <50% without occurrence of MACE)	30 days
Secondary	Optical Coherence Tomography (OCT) Imaging on a Subset of Patients	Qualitative measures in a subset of patients	4 months