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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
REVA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT02539966
First received: September 1, 2015
Last updated: April 25, 2017
Last verified: April 2017
  Purpose
The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.

Condition Intervention
Coronary Artery Disease
Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold

Resource links provided by NLM:


Further study details as provided by REVA Medical, Inc.:

Primary Outcome Measures:
  • Major Adverse Cardiac Events (MACE) - Cohort A and B [ Time Frame: 6 months ]
    Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB >5X ULN) (MI), and target lesion revascularization (TLR)

  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort A [ Time Frame: 6 months ]
    Late Lumen Loss


Secondary Outcome Measures:
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 9 months ]
    Late Lumen Loss

  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort A [ Time Frame: 6 months ]
    Minimum Lumen Diameter (MLD)

  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 9 months ]
    Minimum Lumen Diameter (MLD)

  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort A [ Time Frame: 6 months ]
    % Diameter Stenosis

  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 9 months ]
    % Diameter Stenosis

  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort A [ Time Frame: 6 months ]
    Binary Restenosis

  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 9 months ]
    Binary Restenosis

  • Major Adverse Cardiac Events (MACE) - Cohort A and B [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB >5X ULN) (MI), and target lesion revascularization (TLR)

  • Target Lesion Revascularization (TLR) - Cohort A and B [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Percentage of patients with TLR at each time point

  • Target Vessel Revascularization (TVR) - Cohort A and B [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Percentage of patients with TVR at each time point

  • Target Vessel Failure (TVF) - Cohort A and B [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Percentage of patients with TVF at each time point

  • Acute Technical Success - Cohort A and B [ Time Frame: Day 0 ]
    Successful acute delivery and deployment of the device

  • Procedural Success - Cohort A and B [ Time Frame: 30 days ]
    Percentage of patients with angiographic success (final diameter stenosis <50% without occurrence of MACE)


Estimated Enrollment: 220
Study Start Date: March 2015
Estimated Study Completion Date: October 2020
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up)
Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease
Experimental: Cohort B
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up)
Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Target lesion length must be ≤ 20mm
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02539966

Locations
Australia
The Prince Charles Hospital
Chermside, Australia
St Vincent's Hospital Sydney
Darlinghurst, Australia
Prince of Wales Hospital (Eastern Heart)
Randwick, Australia
Belgium
Cardiovascular Center Aalst
Aalst, Belgium
Brazil
Instituto Dante Pazzanese de Cardiologia
Sao Paulo, Brazil
Albert Einstein Hospital
São Paulo, Brazil
Denmark
Aarhus University Hospital (Skejby)
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
France
institut Hospitalier J.Cartier
Massy, France
La Pitié-Salpétrière
Paris, France
Clinique Pasteur
Toulouse, France
Hôpital Rangueil
Toulouse, France
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, Germany
Netherlands
Academic Medical Center Amsterdam
Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Poland
Krakowskie Centrum Kardiologii Inwazyjnej
Krakow, Poland
Szpital Uniwersytecki w Krakowie
Krakow, Poland
Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
Poznan, Poland
Oddział Kardiologii Inwazyjnej I Katedra
Warszawa, Poland
Sponsors and Collaborators
REVA Medical, Inc.
Investigators
Principal Investigator: Alexandre Abizaid, MD, PhD Instituto Dante Pazzanese de Cardiologia
Principal Investigator: Christoph K Naber, PD Dr. med Elisabeth-Krankenhaus Essen
  More Information

Responsible Party: REVA Medical, Inc.
ClinicalTrials.gov Identifier: NCT02539966     History of Changes
Other Study ID Numbers: HCT6200
Study First Received: September 1, 2015
Last Updated: April 25, 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 27, 2017