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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02539966
Ethics application status
Date submitted
1/09/2015
Date registered
3/09/2015
Date last updated
14/06/2024

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
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Timepoint [2] 0 0
6 months
Secondary outcome [1] 0 0
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Timepoint [1] 0 0
9 months
Secondary outcome [2] 0 0
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Timepoint [3] 0 0
9 months
Secondary outcome [4] 0 0
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Timepoint [5] 0 0
9 months
Secondary outcome [6] 0 0
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Timepoint [7] 0 0
9 months
Secondary outcome [8] 0 0
Major Adverse Cardiac Events (MACE) - Cohorts A, B and C
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
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
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
Timepoint [11] 0 0
12, 24, 36, 48 and 60 months
Secondary outcome [12] 0 0
Acute Technical Success - Cohorts A, B and C
Timepoint [12] 0 0
Day 0
Secondary outcome [13] 0 0
Procedural Success - Cohorts A, B and C
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
Sex
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
220
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02539966