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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02539966




Registration number
NCT02539966
Ethics application status
Date submitted
1/09/2015
Date registered
3/09/2015
Date last updated
14/11/2017

Titles & IDs
Public title
Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
Scientific title
Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
Secondary ID [1] 0 0
HCT6200
Universal Trial Number (UTN)
Trial acronym
FANTOM II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold

Experimental: Cohort A - Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up)

Experimental: Cohort B - Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up)

Experimental: Cohort C - Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group C (6-month angiographic follow-up), Long Lesion/Multi-Vessel


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

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C - Late Lumen Loss
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B - Late Lumen Loss
Timepoint [1] 0 0
9 months
Secondary outcome [2] 0 0
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C - Minimum Lumen Diameter (MLD)
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B - Minimum Lumen Diameter (MLD)
Timepoint [3] 0 0
9 months
Secondary outcome [4] 0 0
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C - % Diameter Stenosis
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B - % Diameter Stenosis
Timepoint [5] 0 0
9 months
Secondary outcome [6] 0 0
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C - Binary Restenosis
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B - Binary Restenosis
Timepoint [7] 0 0
9 months
Secondary outcome [8] 0 0
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)
Timepoint [8] 0 0
12, 24, 36, 48 and 60 months
Secondary outcome [9] 0 0
Target Lesion Revascularization (TLR) - Cohorts A, B and C - Percentage of patients with TLR at each time point
Timepoint [9] 0 0
12, 24, 36, 48 and 60 months
Secondary outcome [10] 0 0
Target Vessel Revascularization (TVR) - Cohorts A, B and C - Percentage of patients with TVR at each time point
Timepoint [10] 0 0
12, 24, 36, 48 and 60 months
Secondary outcome [11] 0 0
Target Vessel Failure (TVF) - Cohorts A, B and C - Percentage of patients with TVF at each time point
Timepoint [11] 0 0
12, 24, 36, 48 and 60 months
Secondary outcome [12] 0 0
Acute Technical Success - Cohorts A, B and C - Successful acute delivery and deployment of the device
Timepoint [12] 0 0
Day 0
Secondary outcome [13] 0 0
Procedural Success - Cohorts A, B and C - Percentage of patients with angiographic success (final diameter stenosis <50% without occurrence of MACE)
Timepoint [13] 0 0
30 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Prince of Wales Hospital (Eastern Heart) - Randwick
Recruitment postcode(s) [1] 0 0
- Chermside
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Aalst
Country [2] 0 0
Brazil
State/province [2] 0 0
Sao Paulo
Country [3] 0 0
Brazil
State/province [3] 0 0
São Paulo
Country [4] 0 0
Denmark
State/province [4] 0 0
Aarhus
Country [5] 0 0
Denmark
State/province [5] 0 0
Copenhagen
Country [6] 0 0
Denmark
State/province [6] 0 0
Odense
Country [7] 0 0
France
State/province [7] 0 0
Massy
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
France
State/province [9] 0 0
Toulouse
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Coburg
Country [12] 0 0
Germany
State/province [12] 0 0
Dortmund
Country [13] 0 0
Germany
State/province [13] 0 0
Erlangen
Country [14] 0 0
Germany
State/province [14] 0 0
Essen
Country [15] 0 0
Germany
State/province [15] 0 0
Kiel
Country [16] 0 0
Netherlands
State/province [16] 0 0
Amsterdam
Country [17] 0 0
Netherlands
State/province [17] 0 0
Rotterdam
Country [18] 0 0
Netherlands
State/province [18] 0 0
Utrecht
Country [19] 0 0
Poland
State/province [19] 0 0
Krakow
Country [20] 0 0
Poland
State/province [20] 0 0
Poznan
Country [21] 0 0
Poland
State/province [21] 0 0
Warszawa

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
REVA Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable
Coronary Scaffold in native coronary arteries.
Trial website
https://clinicaltrials.gov/show/NCT02539966
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alexandre Abizaid, MD, PhD
Address 0 0
Instituto Dante Pazzanese de Cardiologia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jeffrey Anderson
Address 0 0
Country 0 0
Phone 0 0
858-966-3038
Fax 0 0
Email 0 0
janderson@revamedical.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02539966