Safety and Efficacy Study of the Amaranth Medical MAGNITUDE Bioresorbable Drug-Eluting Coronary Stent (RENASCENT III)

NCT02900937 | Unknown Phase 2 DMC

• 1 other identifier: TP-0183(B)
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 13

Brief Summary

The purpose of this study is to evaluate the safety and performance of a new version of a coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle. The Amaranth Medical MAGNITUDE 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.

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)

• 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 containing the scaffold.

  9 months

• 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 Expert Consensus Document from the Society for Cardiovascular Angiography and Interventions), or clinically indicated target lesion revascularization (using the ARC definition).

  9 months

Secondary Outcomes (3)

• 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

• Vessel patency

  2 years

Other Outcomes (10)

• In-segment late lumen loss

  9 months

• In-scaffold and in-segment binary restenosis rate

  9 months and 2 years

• In-scaffold percent volume obstruction

  9 months

Study Arms (1)

Coronary Scaffold Implantation

EXPERIMENTAL

AmM MAGNITUDE Bioresorbable Drug-Eluting Coronary Scaffold

Device: AmM MAGNITUDE Bioresorbable Drug-Eluting Coronary Scaffold

Interventions

AmM MAGNITUDE 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.
• Angiographic
• Patient indicated for elective stenting of up to two de novo native coronary artery lesions.
• If two lesions are to be treated, they must either be located in two separate epicardial vessels (side branches are considered separate vessels) or if located within a single epicardial vessel be separated by ≥ 15 mm of angiographically normal vessel.
• If an elective percutaneous intervention for two different lesions is planned, one of the following situations must apply:
• If both lesions are suitable for stenting with the MAGNITUDE™ scaffold, both lesions can be treated during the same procedure. In case a staging strategy is chosen, no minimum period between the staged interventions is required. In either strategy, the distal lesion must be intended to be treated first and before the proximal lesion.
• If one lesion is intended to be treated with a litmus-based metallic DES and the second lesion is a study lesion (e.g., suitable for stenting with the MAGNITUDE™ scaffold), the two lesions must be located in two different epicardial vessels (side branches are considered separate vessels). Both lesions can be treated during the same procedure. In case a staging strategy is chosen, no minimum period between the staged interventions is required. However, all of the following conditions must apply:

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), sirolimus or its derivatives, poly (L-lactide), poly (D,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 study lesion(s) (e.g., suitable for stenting with the MAGNITUDE™ scaffold).
• 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 (13)

Clinica de Marly

Bogotá, Colombia

NOT YET RECRUITING

Instituto del Corazon

Bucaramanga, Colombia

RECRUITING

Angiografia De Occidente S.A.

Cali, Colombia

RECRUITING

EMMSA Clinica Especializada

Medellín, Colombia

RECRUITING

Azienda Policlinico-Vittorio Emanuele, Universita di Catania

Catania, Italy

NOT YET RECRUITING

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

NOT YET RECRUITING

Azienda Ospedaliera Fatebenefratelli e Oftalmico

Milan, Italy

NOT YET RECRUITING

IRCCS Instituto Clinico Humanitas

Milan, Italy

NOT YET RECRUITING

Ospedale San Raffaele

Milan, Italy

NOT YET RECRUITING

Policlinico San Donato

Milan, Italy

NOT YET RECRUITING

A. O. U. Federico II˚ Policlinico

Napoli, Italy

NOT YET RECRUITING

Policlinico Universitario, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua

Padua, Italy

NOT YET RECRUITING

A. O. Ordine Mauriziano Umberto I

Torino, Italy

NOT YET RECRUITING

Related Publications (4)

• 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

• Colombo A, for the FORTITUDE Study Investigators. 1-Year Clinical and Imaging Outcomes of a Novel Ultra High Molecular Weight PLLA Sirolimus-Eluting Coronary BRS: A Prospective Multicenter International Investigation (The FORTITUDE® Study). TCT presentation 2016.

  BACKGROUND

• Granada JF. From Aptitude to Magnitude: Progress Towards the Development of a Thin-Walled Novel PLLA Based Bioresorbable Scaffold. TCT presentation 2016.

  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

• Antonio Colombo, MD

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew J Ford, Jr., BS

CONTACT

+1 650 965 3830; aford@amaranthmedical.com

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: September 9, 2016
• First Posted: September 15, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: June 1, 2022
• Last Updated: November 25, 2016

Record last verified: 2016-11

Locations

IT (9); CO (4)