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Feasibility Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent (MEND II)

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ClinicalTrials.gov Identifier: NCT02189499
Recruitment Status : Unknown
Verified June 2016 by Amaranth Medical Inc..
Recruitment status was:  Active, not recruiting
First Posted : July 14, 2014
Last Update Posted : June 8, 2016
Sponsor:
Information provided by (Responsible Party):
Amaranth Medical Inc.

Tracking Information
First Submitted Date  ICMJE July 9, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date June 8, 2016
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2014)
  • Incidence of target vessel failure [ Time Frame: 9 months ]
    Defined as the composite rate of cardiac death (using the Academic Research Consortium [ARC] definition), target vessel myocardial infarction (using the Third Universal Definition of MI), or clinically indicated target lesion revascularization (using the ARC definition).
  • In-scaffold late lumen loss [ Time Frame: 9 months ]
    Defined as the amount of vessel lumen diameter (in mm) lost/gained at the time of follow-up compared to the immediate post-treatment result, as measured by quantitative coronary angiography (QCA). The assessment is made within the segment of vessel including the scaffold.
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
  • Incidence of target vessel failure [ Time Frame: 9 months ]
    Defined as composite rate of cardiac death (using the Academic Research Consortium [ARC] definition), target vessel myocardial infarction (using the Third Universal Definition of MI), or clinically indicated target lesion revascularization (using the ARC definition).
  • In-scaffold late lumen loss [ Time Frame: 9 months ]
    Measured using quantitative coronary angiography (QCA).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2014)
  • Clinical device success [ Time Frame: intraoperative ]
    Defined as successful delivery and deployment of the investigational scaffold at the intended target lesion with attainment of a final residual stenosis of < 50% of the target lesion by quantitative coronary angiography (QCA) after the index procedure.
  • Clinical procedure success [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 1-2 days ]
    Defined as successful delivery and deployment of the investigational scaffold at the intended target lesion, with attainment of a final residual stenosis of < 50% of the target lesion by quantitative coronary angiography (QCA) using any adjunctive device, without the occurrence of major adverse clinical events (cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization) during the duration of the subject's hospital stay (an average of 1-2 days).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
  • Clinical device success [ Time Frame: End of index procedure ]
    Defined as successful delivery and deployment of the investigational scaffold at the intended target lesion with attainment of a final residual stenosis of < 50% of the target lesion by quantitative coronary angiography (QCA) after the index procedure.
  • Clinical procedure success [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 1-2 days ]
    Defined as successful delivery and deployment of the investigational scaffold at the intended target lesion, with attainment of a final residual stenosis of < 50% of the target lesion by quantitative coronary angiography (QCA) using any adjunctive device, without the occurrence of major adverse clinical events (cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization) during the duration of the subject's hospital stay (an average of 1-2 days).
Current Other Pre-specified Outcome Measures
 (submitted: October 16, 2014)
  • In-segment/in-scaffold late lumen loss [ Time Frame: 9 months and 2 years ]
    Defined as the amount of vessel lumen diameter (in mm) lost/gained at the time of follow-up compared to the immediate post-treatment result, as measured by quantitative coronary angiography; the assessment is made both within the scaffold itself ("in-scaffold") and within the segment of vessel including the scaffold and 5 mm proximal and distal to the scaffold ("in-segment").
  • In-scaffold percent volume obstruction [ Time Frame: 9 months and 2 years ]
    Defined as the difference between the volume enclosed within the scaffold and the corresponding vessel lumen, expressed as a percentage of the scaffold volume at the time of follow-up, measured using optical coherence tomography (OCT)
  • Stent thrombosis [ Time Frame: Hospital discharge, 30 days, 9 months, and 2 years ]
    Defined using the ARC "definite" or "probable" stent thrombosis definitions.
  • In-scaffold/in-segment binary restenosis rate [ Time Frame: 9 months and 2 years ]
    Defined as the percentage of treated coronary lesions with a residual diameter stenosis over 50% at the time of follow-up, as measured by quantitative coronary angiography (QCA). The assessments are made both within the scaffold itself ("in-scaffold") and within the segment of vessel including the scaffold and 5 mm proximal and distal to the scaffold ("in-segment").
  • Incomplete scaffold strut apposition to the vessel wall [ Time Frame: 9 months and 2 years ]
    Defined as the number (or percentage) of scaffold struts not in direct contact with the vessel wall, either persisting from the implantation of the scaffold or newly occurring after the time of scaffold implantation, assessed at follow-up using OCT.
Original Other Pre-specified Outcome Measures
 (submitted: July 10, 2014)
  • In-segment/in-scaffold late lumen loss [ Time Frame: 9 months and 2 years ]
    The amount of vessel lumen diameter (in mm) lost/gained at the time of follow-up compared to the immediate post-treatment result, as measured by quantitative coronary angiography; the assessment is made both within the scaffold itself ("in-scaffold") and within the segment of vessel including the scaffold and 5 mm proximal and distal to the scaffold ("in-segment").
  • In-scaffold percent volume obstruction [ Time Frame: 9 months and 2 years ]
    The difference between the volume enclosed within the scaffold and the corresponding vessel lumen, expressed as a percentage of the scaffold volume at the time of follow-up, measured using optical coherence tomography (OCT)
  • Stent thrombosis [ Time Frame: Hospital discharge, 30 days, 9 months, and 2 years ]
    Defined using the ARC "definite" or "probable" stent thrombosis definitions.
  • Binary restenosis rate [ Time Frame: 9 months and 2 years ]
    The percentage of treated coronary lesions with a residual diameter stenosis over 50% at the time of follow-up, as measured by quantitative coronary angiography.
  • Incomplete scaffold strut apposition to the vessel wall [ Time Frame: 9 months and 2 years ]
    The number (or percentage) of scaffold struts not in direct contact with the vessel wall, either persisting from the implantation of the scaffold or newly occurring after the time of scaffold implantation, assessed at follow-up using OCT.
 
Descriptive Information
Brief Title  ICMJE Feasibility Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent
Official Title  ICMJE Amaranth Endovascular Study of a Drug-Eluting Bioresorbable Coronary Scaffold
Brief Summary The purpose of this study is to evaluate the safety and feasibility of a new coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle. The Amaranth FORTITUDE scaffold releases a drug (sirolimus) to reduce the likelihood of the treated blood vessel developing a new blockage. In addition, the scaffold dissolves away over time, leaving no permanent implant after the blood vessel has healed. This study will will be the first evaluation of this stent in humans.
Detailed Description

The objective of this first-in-man study is to evaluate the safety and feasibility of the AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold for use in the treatment of single, de novo, stenotic native coronary artery lesions in patients undergoing elective percutaneous coronary intervention. The scaffold is a single-use device comprised of a balloon-expandable, intracoronary drug coated scaffold pre-mounted on a rapid-exchange delivery catheter. The scaffold is made of Poly-L-Lactide (PLLA) and is coated with a polymer-antiproliferative drug (sirolimus) matrix. The scaffold provides mechanical support similar to a metallic stent to the vessel while it is healing, and then gradually breaks down over time leaving no permanent implant in the treated vessel.

The study design is a prospective, non-randomized, feasibility trial. It will enroll a maximum of 50 patients from multiple investigational centers in Columbia. Eligible patients who are at least 18 years of age diagnosed with symptomatic ischemic disease due to a discrete, single, de novo, stenotic lesion in native coronary artery will be asked to participate in this study. After treatment with the investigational device, subjects will be followed for five years. Safety of the device will be evaluated using the incidence of target vessel failure during the follow-up period. Efficacy will be assessed using the in-scaffold late lumen loss measured by quantitative coronary angiography at nine months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Myocardial Ischemia
Intervention  ICMJE Device: AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold
Placement of the investigational device into the diseased coronary artery to eliminate the vascular stenosis.
Other Name: Coronary stent
Study Arms  ICMJE Experimental: Coronary Scaffold Implantation
AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold
Intervention: Device: AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold
Publications *
  • Granada JF. The Amaranth PLLA based bioresorbable scaffold (ABRS): Experimental and early human results. TCT presentation 2013.
  • Granada JF. BRS with clinical data III, Amaranth: Differentiating features and clinical update. TCT presentation 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: June 6, 2016)
42
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2014)
50
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

General

  1. Subject is ≥ 18 years of age and < 85 years of age.
  2. Subject agrees not to participate in any other investigational device or drug study for a period of two years following the index procedure. Questionnaire-based studies, or other studies that are non-invasive and do not require investigational devices or medications are allowed.
  3. Subject (or their legally authorized representative) provides written informed consent prior to any study-related procedure, using the form approved by the local Ethics Committee.
  4. Subject has:

    1. evidence of myocardial ischemia (e.g., stable angina [Canadian Cardiovascular Society 1, 2, 3, or 4] or unstable angina [Braunwald Class 1-3, B-C], or silent ischemia with supporting imaging studies [ETT, SPECT, stress echocardiography, or Cardiac CT]), or
    2. low or intermediate risk NSTEMI, or
    3. evidence of myocardial ischemia in a coronary territory previously affected by STEMI as long as the lesion fulfills the angiographic inclusion criteria and the intervention performed ≥ 6 months following the clinical event.
  5. Subject is an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  6. Patient agrees to complete all protocol required follow-up visits, including angiograms and OCT exams.
  7. Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥ 30 days prior to or planned to be done ≥ 9 months after the index procedure.
  8. Percutaneous interventions for lesions in the target vessel are allowed if done ≥ 6 months prior to or planned to be done ≥ 9 months after the index procedure.

Angiographic

  1. Patient indicated for elective stenting of a single, de novo, stenotic lesion in a native coronary artery.
  2. Target lesion must measure ≤ 14 mm in length by on-line QCA.
  3. Lesion must be located in a native coronary artery with a diameter (average of distal and proximal to lesion by IVUS) of 2.5 mm to 3.7 mm.
  4. Target lesion must be in a major artery or branch with a visually estimated diameter stenosis of ≥ 50% and < 100% with a Thrombolysis in Myocardial Infarction (TIMI) flow of ≥ 1.

Exclusion Criteria:

General

  1. Patient has known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel, and ticagrelor), poly (L-lactide), platinum-iridium, or contrast sensitivity that cannot be adequately pre-medicated.
  2. Patient has evolving ST segment elevation myocardial infarction (STEMI).
  3. Patient has current unstable arrhythmias.
  4. Patient has a left ventricular ejection fraction (LVEF) < 30%.
  5. Patient has received a heart transplant or any other organ transplant, or is on a waiting list for any organ transplant.
  6. Patient has any previous stent placements ≤ 15 mm (proximal or distal) of the target lesion.
  7. Patient is receiving or scheduled to receive chemotherapy for malignancy ≤ 30 days prior to or after the index procedure.
  8. Patient is receiving immunosuppressant therapy and/or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, severe asthma requiring immunosuppressive medication, etc.).
  9. Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, Coumadin) that cannot be stopped and restarted according to local hospital standard procedures.
  10. Elective surgery is planned ≤ 9 months after the index procedure that will require discontinuation of anti-platelet medications.
  11. Patient has a platelet count < 100,000 cells/mm^3 or > 700,000 cells/mm^3, a WBC of < 3,000 cells/mm^3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
  12. Patient has known renal insufficiency (e.g., eGFR < 60 ml/kg/m^2 or serum creatinine level of > 2.5 mg/dL, or subject on dialysis).
  13. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  14. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) ≤ 6 months prior to the index procedure.
  15. Patient has had a significant GI or urinary bleed ≤ 6 months prior to the index procedure.
  16. Patient has extensive peripheral vessel disease that precludes safe introducer sheath insertion.
  17. Patient has received brachytherapy in any epicardial vessel (including side branches).
  18. Pregnant or nursing subjects and those who plan pregnancy ≤ 2 years following index procedure. (Note: Female subjects of child-bearing potential must have a negative pregnancy test ≤ 28 days prior to the index procedure and agree to use contraception for 2 years.)
  19. Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy (i.e., ≤ 1 year).
  20. Subject belongs to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff, mentally deficient, or unable to read or write).

Angiographic Exclusion

  1. Target lesion meets any of the following criteria:

    1. Aorto-ostial location (within ≤ 3 mm of aorta junction).
    2. Left Main location.
    3. Located ≤ 3 mm of the origin of the left anterior descending (LAD) or left coronary circumflex (LCX).
    4. Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion, by visual estimation) arterial or saphenous vein graft.
    5. Lesion involving a bifurcation > 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation.
    6. Total occlusion (TIMI flow 0) prior to wire crossing.
    7. Excessive tortuosity (≥ two 45° angles), or extreme angulation (≥ 90°) proximal to or within the target lesion.
    8. Restenotic from previous intervention.
    9. Moderate to severe superficial calcification (defined as calcium arch > 120°) proximal to or within the target lesion.
  2. Target lesion involves myocardial bridge.
  3. Target vessel contains visible thrombus as indicated in the angiographic images.
  4. Another clinically significant lesion is located in the same major epicardial vessel as the target lesion (including side branches).
  5. Inadequate pre-dilation of the target lesion (residual stenosis > 40% by visual assessment).
  6. Patient has a high probability that the use of other ancillary devices such as atherectomy or cutting balloon will be required at the time of index procedure for treatment of the target vessel.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189499
Other Study ID Numbers  ICMJE TP-0170
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Amaranth Medical Inc.
Study Sponsor  ICMJE Amaranth Medical Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juan F Granada, MD Skirball Center for Cardiovascular Research, Columbia University Medical Center
PRS Account Amaranth Medical Inc.
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP