Safety and Efficacy Study of the Amaranth Medical APTITUDE Bioresorbable Drug-Eluting Coronary Stent (RENASCENT II)
|ClinicalTrials.gov Identifier: NCT02568462|
Recruitment Status : Active, not recruiting
First Posted : October 6, 2015
Last Update Posted : June 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Myocardial Ischemia||Device: AmM APTITUDE Bioresorbable Drug-Eluting Coronary Scaffold||Phase 2|
The objective of this study is to evaluate the safety and performance of the AmM APTITUDE 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. Compared to prior versions of the scaffold, the new device has a thinner strut design (a wall thickness of 120 µm rather than 150 µm), but is otherwise identical.
The study design is a prospective, non-randomized, multi-center, non-inferiority trial. It will enroll a maximum of 60 patients from up to 12 investigational centers in Colombia and the European Union. 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. Performance (efficacy) will be assessed using the in-scaffold late lumen loss measured by quantitative coronary angiography at nine months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds - Extended Trial II|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||July 2021|
Experimental: Coronary Scaffold Implantation
AmM APTITUDE Bioresorbable Drug-Eluting Coronary Scaffold
Device: AmM APTITUDE Bioresorbable Drug-Eluting Coronary Scaffold
Placement of the investigational device into the diseased coronary artery to eliminate the vascular stenosis.
Other Name: Coronary stent
- In-scaffold late lumen loss [ Time Frame: 9 months ]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.
- Incidence of target vessel failure [ Time Frame: 9 months ]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).
- Clinical device success [ Time Frame: intraoperative ]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.
- Clinical procedure success [ Time Frame: Participants will be followed for the duration of their hospital stay, an expected average of 1-2 days ]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).
- Vessel patency [ Time Frame: 2 years ]Assessed both by the minimum lumen diameter (MLD) and percent diameter stenosis (%DS), each measured at 2 years by either coronary computed tomography angiography (CTA) or quantitative coronary angiography (QCA).
- In-segment late lumen loss [ Time Frame: 9 months ]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 and 5 mm proximal and distal to the scaffold.
- In-scaffold and in-segment binary restenosis rate [ Time Frame: 9 months and 2 years ]Defined as the percentage of treated coronary lesions with a residual diameter stenosis > 50% at the time of follow-up, as measured by quantitative coronary angiography (QCA) or coronary computed tomography angiography (CTA). The assessments are made both within the scaffold itself ("in-scaffold") and within the segment of vessel including the scaffold and 5 mm proximal and distal to the scaffold ("in-segment").
- In-scaffold percent volume obstruction [ Time Frame: 9 months ]Defined as the difference between the volume enclosed within the scaffold and the corresponding vessel lumen, expressed as a percentage of the scaffold volume at the time of follow-up, measured using optical coherence tomography (OCT).
- Incomplete scaffold strut apposition to the vessel wall [ Time Frame: 9 months ]Defined as the number (or percentage) of scaffold struts not in direct contact with the vessel wall, either persisting from the implantation of the scaffold or newly occurring after the time of scaffold implantation, assessed at follow-up using optical coherence tomography (OCT).
- Stent Thrombosis [ Time Frame: Hospital discharge, 30 days, 9 months, and 2 years ]Defined using the Academic Research Consortium (ARC) "definite" or "probable" stent thrombosis definitions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568462
|Clinica de Marly|
|Instituto del Corazon|
|Angiografia De Occidente S.A.|
|EMMSA Clinica Especializada|
|Azienda Policlinico-Vittorio Emanuele, Universita di Catania|
|Azienda Ospedaliero Universitaria Careggi|
|Azienda Ospedaliera Fatebenefratelli e Oftalmico|
|Ospedale San Raffaele|
|Policlinico San Donato|
|A. O. U. Federico II˚ Policlinico|
|Policlinico Universitario, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua|
|A. O. Ordine Mauriziano Umberto I|
|Principal Investigator:||Antonio Colombo, MD||Ospedale San Raffaele|