Peripheral Vascular Disease
Conditions
Brief summary
The aim of this study is to prospectively collect information to evaluate the safety and performance of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral scaffold system for the treatment of symptomatic primary atherosclerotic stenoses and occlusions of the superficial femoral artery (SFA).
Detailed description
This is a mutli center, prospective ,single arm study enrolling up to 60 patients at up to 12 centers in New Zealand and Europe. The purpose is to prospectively collect information to evaluate the safety and performance of the Akesys Prava Sirolimus eluting bioresorbable scaffold system in peripheral arterial disease (PAD) Patients will be treated with the investigational device and followed up clinically at 1 month, 6 Months, 12 months, 24 months and 36 months post procedure. Patients will undergo non-invasive assessments such as Duplex Ultrasound (DUS), Ankle/Brachial Index (ABI) measurements and will complete a Walking Impairment Questionnaire (WIQ) and Quality of Life Questionnaire (VASCUQoL) at each follow up interval. Data will be collected via electronic data capture (EDC) and reportable Events will be reviewed by a medical monitor and classified using the MedDRA system. The information entered by the research centres will be source data verified (monitored) by an independent Contract Research Organisation (CRO.) A Data Monitoring Committee (DMC) with appropriately qualified members independent of the study will meet to review and adjudicate on events at predetermined intervals, according to the charter. Primary safety and efficacy endpoints will be evaluated at 6 months There will be no formal hypothesis testing in the study, endpoints will be evaluated with 95% confidence intervals around the observed point estimates. The endpoints will be evaluated with Kaplan-Meier methodology.
Interventions
DEVICEAkesys Prava Scaffold
Implantation of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral Scaffold System
Sponsors
Syntactx
Massachusetts General Hospital
Genae
Elixir Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical inclusion criteria: 1. Subject is ≥18 years of age. 2. Subject has been informed of the nature of the study, agrees to its provisions, is able to provide informed consent, and agrees to undergo all protocol-required follow up examinations and requirements. 3. Subject's life expectancy is at least 1 year. 4. Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 2-4). 5. For females of childbearing potential, a negative pregnancy test within 14 days before index procedure is required 6. Subject is able to take a P2Y12 receptor antagonist (e.g. clopidogrel, ticagrelor, prasugrel or ticagrelor) and acetylsalicylic acid (aspirin). Angiographic inclusion criteria: 1. A single, de novo native disease segment of the SFA 2. Proximal margin of target lesion is ≥1 cm distal to the common femoral artery bifurcation; distal margin of target lesion is within the SFA. 3. Vessel diameter from ≥5.0 mm to ≤6.0 mm evaluated by on-line quantitative vascular angiography (QVA) after pre-dilatation per core laboratory guidelines. 4. Target lesion diameter reduction ≥50% 5. Target lesion length ≤53 mm 6. Patent inflow artery free from significant lesion (≥50% diameter reduction; 7. Patent distal popliteal artery free from significant lesion (≥50%) with angiographic demonstration of at least one fully patent distal outflow artery (anterior tibial, posterior tibial, or peroneal) to its terminus.
Exclusion criteria
Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from composite of perioperative death < 30 days and freedom from major adverse limb events (MALE) defined as the occurrence of major amputation, thrombectomy, thrombolysis or major open surgical revascularization | 6 months | Primary Safety Endpoint |
| Primary Patency defined as the freedom from restenosis (>50% diameter reduction defined by Duplex Ultrasound) or clinically driven target lesion revascularization through 6 months | 6 months | Primary Effectiveness Endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success defined as < 30%residual stenosis after successful implantation of the scaffold assessed by angiography at the conclusion of the procedure | Post Procedure, procedure may take up to 2 hours | The assessment will be made and evaluated at the conclusion of the index procedure |
| Freedom from composite of perioperative death within 30 days and freedom from major adverse limb events (MALE) defined as the occurrence of major amputation, thrombectomy, thrombolysis or major open surgical revascularization. | 12 months | Secondary Safety endpoint |
| Freedom from the composite of target lesion (TL) occlusion, reintervention or restenosis defined as a >50% diameter reduction in the target lesion, as confirmed by Duplex Ultrasound or angiography | 12 months | Secondary Effectiveness Endpoint |
| All cause mortality | 12 months | — |
| Technical Success defined as the successful delivery and deployment of the device assessed by angiography at the conclusion of the procedure | Post Procedure- Procedure may take up to 2 hours | The assessment will be made and evaluated at the conclusion of the index procedure |
| Technical Success defined as no implantation of metallic stent assessed by angiography at the conclusion of the procedure | Post Procedure, procedure may take up to 2 hours | the assessment will be made and evaluated at the conclusion of the Index procedure |
| Major target extremity amputation | 1 month,6 months,12 months, 24 months, 36 months | — |
| Minor target extremity amputation | 1 month,6 months,12 months, 24 months, 36 months | — |
| Clinically driven target lesion restenosis defined as any intervention due to worsening symptoms, a fall in ABI or TL restenosis as determined by duplex ultrasound | 1 month,6 months,12 months, 24 months, 36 months | — |
| Scaffold Thrombosis | 1 month,6 months,12 months, 24 months, 36 months | — |
| Primary patency of the target lesion | 1 month,6 months,12 months, 24 months, 36 months | — |
| Primary assisted patency of the target lesion | 1 month,6 months,12 months, 24 months, 36 months | — |
| Secondary patency of the target lesion | 1 month,6 months,12 months, 24 months, 36 months | — |
| Rutherford Becker clinical category | 1 month,6 months,12 months, 24 months, 36 months | — |
| Ankle Brachial Index in the target extremity | 1 month,6 months,12 months, 24 months, 36 months | — |
| Walking Capacity as demonstrated by the Walking Impairment Questionnaire | 1 month,6 months,12 months, 24 months, 36 months | — |
| Quality of Life measures using VASCUQoL- disease specific | 1 month,6 months,12 months, 24 months, 36 months | — |
| Duplex ultrasound derived Peak Velocity (PSV) at the target lesion | 1 month,6 months,12 months, 24 months, 36 months | — |
| Target extremity revascularisation | 1 month,6 months,12 months, 24 months, 36 months | — |
| Target Lesion binary restenosis by duplex ultrasound Peak Systolic Velocity ratio (PSVR>2.4) | 1 month, 6 months,12 months, 24 months, 36 months | — |
Countries
Austria, Belgium, Germany, New Zealand
Outcome results
None listed