Safety and Efficacy Study of the Amaranth Medical APTITUDE Bioresorbable Drug-Eluting Coronary Stent

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2016
• Main ID: NCT02568462
• Date of registration: 02/10/2015
• Prospective Registration: Yes
• Primary sponsor: Amaranth Medical Inc.
• Public title: Safety and Efficacy Study of the Amaranth Medical APTITUDE Bioresorbable Drug-Eluting Coronary Stent RENASCENT II
• Scientific title: Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds - Extended Trial II
• Date of first enrolment: November 2015
• Target sample size: 60
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02568462
• 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

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.

7. Elective percutaneous interventions for non-target lesions are allowed if performed =
30 days prior to or following 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), 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 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 involving a myocardial bridge.

3. Target vessel contains visible thrombus as indicated in the angiogra


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

Health Condition(s) or Problem(s) studied

Myocardial Ischemia

Coronary Artery Disease

Intervention(s)

Device: AmM APTITUDE Bioresorbable Drug-Eluting Coronary Scaffold

Primary Outcome(s)

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

Incidence of target vessel failure [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]

Clinical device success [Time Frame: intraoperative]

Vessel patency [Time Frame: 2 years]

Secondary ID(s)

TP-0182(C)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors