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

• Register: ClinicalTrials.gov
• Last refreshed on: 5 December 2016
• Main ID: NCT02900937
• Date of registration: 09/09/2016
• Prospective Registration: Yes
• Primary sponsor: Amaranth Medical Inc.
• Public title: Safety and Efficacy Study of the Amaranth Medical MAGNITUDE Bioresorbable Drug-Eluting Coronary Stent (RENASCENT III) RENASCENT III
• Scientific title: Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds - Extended Trial III
• Date of first enrolment: October 2016
• Target sample size: 70
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02900937
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Colombia, Italy

Contacts

• Name: Antonio Colombo, MD
• Affiliation: Ospedale San Raffaele

• Name: Andrew J Ford, Jr., BS

Key inclusion & exclusion criteria

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 = 3 months following the STEMI.

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.

Angiographic

1. Patient indicated for elective stenting of up to two de novo native coronary artery
lesions.

2. 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.

3. If an elective percutaneous intervention for two different lesions is planned, one of
the following situations must apply:

1. 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.

2. 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:

- Non-study lesion must be successfully treated without clinically
significant complications prior to treatment of the study lesion.

- Non-study lesion must be = 30 mm in length.

- Reference vessel diameter for the non-study lesion must be = 2.75 mm by
QCA.

- Non-study lesion does not involve left main stenting, bifurcation stenting,
chronic total occlusion, or high thrombotic burden.

4. Each study lesion (e.g., suitable for stenting with the MAGNITUDE™ scaffold) must
measure = 14 mm in length by on-line QCA.

5. Each study lesion (e.g., suitable for stenting with the MAGNITUDE™ scaffold) 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 3.5 mm.

6. Each study lesion (e.g., suitable for stenting with the MAGNITUDE™ scaffold) must be
in a major artery/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), sirolimus or its derivatives, poly (L-lactide), poly
(D,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 study
lesion(s) (e.g., suitable for stenting with the MAGNITUDE™ scaffold).

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: S


Age minimum: 18 Years
Age maximum: 84 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Myocardial Ischemia

Intervention(s)

Device: AmM MAGNITUDE Bioresorbable Drug-Eluting Coronary Scaffold

Primary Outcome(s)

Incidence of target vessel failure [Time Frame: 9 months]

In-scaffold late lumen loss [Time Frame: 9 months]

Secondary Outcome(s)

Clinical procedure success [Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 1-2 days]

Vessel patency [Time Frame: 2 years]

Clinical device success [Time Frame: intraoperative]

Secondary ID(s)

TP-0183(B)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors