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Coronary Artery DiseasePhase 2MEND IINCT02189499

Feasibility Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent

A Phase 2 study testing AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold in people with Coronary Artery Disease and Myocardial Ischemia, run by Amaranth Medical Inc. at 4 sites in Colombia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 84 years
Conditions the study is for
Coronary Artery Disease, Myocardial Ischemia
What is being tested?
AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
4 sitesColombia
Study dates
Sep 2014to Nov 2020
Phase
Phase 2
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 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General
  • Subject is ≥ 18 years of age and < 85 years of age.
  • 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.
  • 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.
  • Subject has:
  • 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
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  • low or intermediate risk NSTEMI, or
  • 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.
  • Subject is an acceptable candidate for coronary artery bypass graft (CABG) surgery.
  • Patient agrees to complete all protocol required follow-up visits, including angiograms and OCT exams.
  • 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.
  • 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
  • Patient indicated for elective stenting of a single, de novo, stenotic lesion in a native coronary artery.
  • Target lesion must measure ≤ 14 mm in length by on-line QCA.
  • 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.
  • 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.

Who cannot join

  • General
  • 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.
  • Patient has evolving ST segment elevation myocardial infarction (STEMI).
  • Patient has current unstable arrhythmias.
  • Patient has a left ventricular ejection fraction (LVEF) < 30%.
  • Patient has received a heart transplant or any other organ transplant, or is on a waiting list for any organ transplant.
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  • Patient has any previous stent placements ≤ 15 mm (proximal or distal) of the target lesion.
  • Patient is receiving or scheduled to receive chemotherapy for malignancy ≤ 30 days prior to or after the index procedure.
  • 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.).
  • 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.
  • Elective surgery is planned ≤ 9 months after the index procedure that will require discontinuation of anti-platelet medications.
  • 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).
  • 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).
  • Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) ≤ 6 months prior to the index procedure.
  • Patient has had a significant GI or urinary bleed ≤ 6 months prior to the index procedure.
  • Patient has extensive peripheral vessel disease that precludes safe introducer sheath insertion.
  • Patient has received brachytherapy in any epicardial vessel (including side branches).
  • 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.)
  • 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).
  • 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
  • Target lesion meets any of the following criteria:
  • Aorto-ostial location (within ≤ 3 mm of aorta junction).
  • Left Main location.
  • Located ≤ 3 mm of the origin of the left anterior descending (LAD) or left coronary circumflex (LCX).
  • 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.
  • Lesion involving a bifurcation > 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation.
  • Total occlusion (TIMI flow 0) prior to wire crossing.
  • Excessive tortuosity (≥ two 45° angles), or extreme angulation (≥ 90°) proximal to or within the target lesion.
  • Restenotic from previous intervention.
  • Moderate to severe superficial calcification (defined as calcium arch > 120°) proximal to or within the target lesion.
  • Target lesion involves myocardial bridge.
  • Target vessel contains visible thrombus as indicated in the angiographic images.
  • Another clinically significant lesion is located in the same major epicardial vessel as the target lesion (including side branches).
  • Inadequate pre-dilation of the target lesion (residual stenosis > 40% by visual assessment).
  • 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.

Trial locations and contacts

4 sites in 1 country.

Colombia4 sites

  • Clinica de Marly

    Bogotá

  • Instituto del Corazon

    Bucaramanga

  • Angiografia De Occidente S.A.

    Cali

  • EMMSA Clinica Especializada

    Medellín

Other trials in Colombia

About this study

Official title: Amaranth Endovascular Study of a Drug-Eluting Bioresorbable Coronary Scaffold

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.

Read the 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.

Being tested
AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold
Keywords
Stents, Angioplasty, Coronary Vessels, Coronary Artery Disease, Angina Pectoris, Myocardial Ischemia, Myocardial Infarction, Myocardial Revascularization
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia, Angina Pectoris, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmM FORTITUDE Bioresorbable Drug-Eluting Coronary ScaffoldDevice

    Also called Coronary stent

    Placement of the investigational device into the diseased coronary artery to eliminate the vascular stenosis.

Study groups in NCT02189499
Study groupRoleWhat they receive
Coronary Scaffold ImplantationExperimentalAmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold
Receives: Device: AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of target vessel failure

    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).

    Measured: 9 months

  2. In-scaffold late lumen loss

    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.

    Measured: 9 months

Secondary outcomes (2)

  1. Clinical device success

    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.

    Measured: intraoperative

  2. Clinical procedure success

    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).

    Measured: Participants will be followed for the duration of their hospital stay, an expected average of 1-2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJun 2016 (estimated)
  4. Study completionNov 2020 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02189499
Sponsor's protocol ID
TP-0170
Acronym
MEND II
Status last verified
Jun 2016
First submitted
9 Jul 2014
Last updated
8 Jun 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold in people with Coronary Artery Disease and Myocardial Ischemia, run by Amaranth Medical Inc. at 4 sites in Colombia.

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 17 inclusion and 37 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: status not confirmed, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Colombia. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Incidence of target vessel failure (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02189499, which also lists 2 linked publications.

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 8 Jun 2016.

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