Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold

Coronary Artery Disease Clinical Trial

— FANTOM II  

Official title:

Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02539966
• Other study ID #: HCT6200
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2015
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: REVA Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: September 2024
• Est. primary completion date: August 2019
• 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
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital	Chermside
Australia	St Vincent's Hospital Sydney	Darlinghurst
Australia	Prince of Wales Hospital (Eastern Heart)	Randwick
Belgium	Cardiovascular Center Aalst	Aalst
Brazil	Instituto Dante Pazzanese de Cardiologia	Sao Paulo
Brazil	Albert Einstein Hospital	São Paulo
Denmark	Aarhus University Hospital (Skejby)	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	Odense University Hospital	Odense
France	institut Hospitalier J.Cartier	Massy
France	La Pitié-Salpétrière	Paris
France	Clinique Pasteur	Toulouse
France	Hôpital Rangueil	Toulouse
Germany	Am Urban Hospital, Berlin	Berlin
Germany	Friedrichshein Hospital, Berlin	Berlin
Germany	Klinikum Coburg	Coburg
Germany	St.- Johannes-Hospital Dortmund	Dortmund
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Elisabeth-Krankenhaus Essen	Essen
Germany	Universitätsklinikum Schleswig-Holstein	Kiel
Netherlands	Academic Medical Center Amsterdam	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	University Medical Center Utrecht	Utrecht
Poland	Krakowskie Centrum Kardiologii Inwazyjnej	Krakow
Poland	Szpital Uniwersytecki w Krakowie	Krakow
Poland	Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu	Poznan
Poland	Oddzial Kardiologii Inwazyjnej I Katedra	Warszawa

Sponsors (1)

Lead Sponsor	Collaborator
REVA Medical, Inc.

Countries where clinical trial is conducted

Australia,  Belgium,  Brazil,  Denmark,  France,  Germany,  Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events (MACE) - Cohorts A, B and C	Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB >5X ULN) (MI), and target lesion revascularization (TLR)	6 months
Primary	Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C	Late Lumen Loss	6 months
Secondary	Quantitative Coronary Angiography (QCA) derived parameters - Cohort B	Late Lumen Loss	9 months
Secondary	Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C	Minimum Lumen Diameter (MLD)	6 months
Secondary	Quantitative Coronary Angiography (QCA) derived parameters - Cohort B	Minimum Lumen Diameter (MLD)	9 months
Secondary	Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C	% Diameter Stenosis	6 months
Secondary	Quantitative Coronary Angiography (QCA) derived parameters - Cohort B	% Diameter Stenosis	9 months
Secondary	Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C	Binary Restenosis	6 months
Secondary	Quantitative Coronary Angiography (QCA) derived parameters - Cohort B	Binary Restenosis	9 months
Secondary	Major Adverse Cardiac Events (MACE) - Cohorts A, B and C	Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB >5X ULN) (MI), and target lesion revascularization (TLR)	12, 24, 36, 48 and 60 months
Secondary	Target Lesion Revascularization (TLR) - Cohorts A, B and C	Percentage of patients with TLR at each time point	12, 24, 36, 48 and 60 months
Secondary	Target Vessel Revascularization (TVR) - Cohorts A, B and C	Percentage of patients with TVR at each time point	12, 24, 36, 48 and 60 months
Secondary	Target Vessel Failure (TVF) - Cohorts A, B and C	Percentage of patients with TVF at each time point	12, 24, 36, 48 and 60 months
Secondary	Acute Technical Success - Cohorts A, B and C	Successful acute delivery and deployment of the device	Day 0
Secondary	Procedural Success - Cohorts A, B and C	Percentage of patients with angiographic success (final diameter stenosis <50% without occurrence of MACE)	30 days