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

NCT02189499 | Unknown Phase 2

• 1 other identifier: TP-0170
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 4

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.

Conditions

Coronary Artery Disease; Myocardial Ischemia

Keywords

Stents; Angioplasty; Coronary Vessels; Coronary Artery Disease; Angina Pectoris; Myocardial Ischemia; Myocardial Infarction; Myocardial Revascularization

Outcome Measures

Primary Outcomes (2)

• 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).

  9 months

• 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.

  9 months

Secondary Outcomes (2)

• Clinical device success

  intraoperative

• Clinical procedure success

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

Other Outcomes (5)

• In-segment/in-scaffold late lumen loss

  9 months and 2 years

• In-scaffold percent volume obstruction

  9 months and 2 years

• Stent thrombosis

  Hospital discharge, 30 days, 9 months, and 2 years

Study Arms (1)

Coronary Scaffold Implantation

EXPERIMENTAL

AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold

Device: AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold

Interventions

AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold DEVICE

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

Also known as: Coronary stent

Coronary Scaffold Implantation

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• low or intermediate risk NSTEMI, or
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Amaranth Medical Inc.: lead

Study Sites (4)

Clinica de Marly

Bogotá, Colombia

Location

Instituto del Corazon

Bucaramanga, Colombia

Location

Angiografia De Occidente S.A.

Cali, Colombia

Location

EMMSA Clinica Especializada

Medellín, Colombia

Location

Related Publications (2)

• Granada JF. The Amaranth PLLA based bioresorbable scaffold (ABRS): Experimental and early human results. TCT presentation 2013.

  BACKGROUND

• Granada JF. BRS with clinical data III, Amaranth: Differentiating features and clinical update. TCT presentation 2014.

  BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Angina Pectoris; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Juan F Granada, MD

  Skirball Center for Cardiovascular Research, Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 14, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2020
• Last Updated: June 8, 2016

Record last verified: 2016-06

Locations

CO (4)