Coronary Artery DiseaseFANTOM INCT02512003
Pilot Study of the Fantom Bioresorbable Scaffold (FANTOM I)
A study testing Fantom Scaffold in people with Coronary Artery Disease, run by REVA Medical, Inc. at 2 sites in 2 countries.
Trial summary
The FANTOM I pilot study is intended to assess safety of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Fantom Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Dec 2014to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Poland1 site
Pracownia Kardiologii Inwazyjnej I Katedry i Kliniki Kardiologii WUM
Warsaw
About this study
Official title: Pilot Study of the REVA Sirolimus-Eluting Bioresorbable Coronary Scaffold
The FANTOM I pilot study is intended to assess safety of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.
- Conditions
- Coronary Artery Disease
- Being tested
- Fantom Scaffold
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fantom ScaffoldDevice
| Study group | Role | What they receive |
|---|---|---|
| Fantom Treatment group | Experimental | Not described Receives: Device: Fantom Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemia-driven Target Lesion Revascularization (TLR)
Percent of Patients with TLR at 4 months
Measured: 4 months
Secondary outcomes (17)
Quantitative Coronary Angiography (QCA) derived parameters
Late Loss
Measured: 4 months
Quantitative Coronary Angiography (QCA) derived parameters
Restenosis Rate
Measured: 4 months
Quantitative Coronary Angiography (QCA) derived parameters
% Diameter Stenosis
Measured: 4 months
Quantitative Coronary Angiography (QCA) derived parameters
Minimum Lumen Diameter
Measured: 4 months
Quantitative Coronary Angiography (QCA) derived parameters
Neointimal Volume
Measured: 4 months
Intravascular Ultrasound (IVUS) derived parameters
Late Loss
Measured: 4 months
Intravascular Ultrasound (IVUS) derived parameters
Restenosis Rate
Measured: 4 months
Intravascular Ultrasound (IVUS) derived parameters
% Diameter Stenosis
Measured: 4 months
Intravascular Ultrasound (IVUS) derived parameters
Minimum Lumen Diameter
Measured: 4 months
Intravascular Ultrasound (IVUS) derived parameters
Neointimal Volume
Measured: 4 months
Major Adverse Cardiac Events
Death, Q-Wave Myocardial Infarction, Non Q-Wave Myocardial Infarction (CK-MB > 5x normal), Target Vessel Revascularization
Measured: 12, 24, 36, 48 and 60 months
Target Lesion Revascularization (TLR)
Percentage of patients with TLR at each time point
Measured: 12, 24, 36, 48 and 60 months
Target Vessel Revascularization
Percentage of patients with TVR at each time point
Measured: 12, 24, 36, 48 and 60 months
Target Vessel Failure (TVF)
Percentage of patients with TVF at each time point
Measured: 12, 24, 36, 48 and 60 months
Acute Technical Success
Percentage of patients with successful acute delivery and deployment of the device
Measured: Day 0
Procedural Success
Percentage of patients with angiographic success (final diameter stenosis <50% without occurrence of MACE)
Measured: 30 days
Optical Coherence Tomography (OCT) Imaging on a Subset of Patients
Qualitative measures in a subset of patients
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startDec 2014
- Primary completionJul 2015
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- REVA Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512003
- Sponsor's protocol ID
- HCT6000
- Acronym
- FANTOM I
- Status last verified
- Mar 2023
- First submitted
- 14 Jul 2015
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the REVA Sirolimus-Eluting Bioresorbable Coronary Scaffold
- ClinicalTrials.gov ID
- NCT02512003
- Acronym / sponsor ID
- FANTOM I / HCT6000
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- REVA Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The FANTOM I pilot study is intended to assess safety of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fantom Treatment group | Experimental | Device: Fantom Scaffold |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fantom Scaffold | Device | Fantom Treatment group |
Primary outcome
Ischemia-driven Target Lesion Revascularization (TLR)
Time frame: 4 months
Percent of Patients with TLR at 4 months
17 secondary outcomes
Quantitative Coronary Angiography (QCA) derived parameters
Time frame: 4 months
Quantitative Coronary Angiography (QCA) derived parameters
Time frame: 4 months
Quantitative Coronary Angiography (QCA) derived parameters
Time frame: 4 months
Quantitative Coronary Angiography (QCA) derived parameters
Time frame: 4 months
Quantitative Coronary Angiography (QCA) derived parameters
Time frame: 4 months
Intravascular Ultrasound (IVUS) derived parameters
Time frame: 4 months
Intravascular Ultrasound (IVUS) derived parameters
Time frame: 4 months
Intravascular Ultrasound (IVUS) derived parameters
Time frame: 4 months
Intravascular Ultrasound (IVUS) derived parameters
Time frame: 4 months
Intravascular Ultrasound (IVUS) derived parameters
Time frame: 4 months
Major Adverse Cardiac Events
Time frame: 12, 24, 36, 48 and 60 months
Target Lesion Revascularization (TLR)
Time frame: 12, 24, 36, 48 and 60 months
Target Vessel Revascularization
Time frame: 12, 24, 36, 48 and 60 months
Target Vessel Failure (TVF)
Time frame: 12, 24, 36, 48 and 60 months
Acute Technical Success
Time frame: Day 0
Procedural Success
Time frame: 30 days
Optical Coherence Tomography (OCT) Imaging on a Subset of Patients
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fantom Scaffold in people with Coronary Artery Disease, run by REVA Medical, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemia-driven Target Lesion Revascularization (TLR) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.