The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery

Official title

A Clinical Evaluation of the Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery

Overview

To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery

Detailed description

The EFEMORAL I study is a prospective, single-arm, open-labeled, multi-center, clinical investigation enrolling patients with arterial diameter of ≥5.5 mm and ≤6.5 mm and lesion length ≤90 mm receiving a single EVSS.

Interventions

• Device Efemoral Vascular Scaffold System (EVSS)
  Balloon-expandable, bioresorbable vascular scaffolds coated with sirolimus

Primary outcome measures

• Major Adverse Event (MAE) [Time frame: 30 days]
• Freedom from Binary Restenosis [Time frame: 12 months]

Secondary outcome measures (12)

• Device Success [Time frame: Day 0]
• Primary patency rate [Time frame: 1, 6, 12, 24 and 36 months]
• Binary restenosis rate [Time frame: 1, 6, 12, 24 and 36 months]
• Target lesion revascularization (TLR) [Time frame: 1, 6, 12, 24 and 36 months]
• Ipsilateral extremity revascularization (IER) [Time frame: 1, 6, 12, 24 and 36 months]
• Number of patients with Scaffold thrombosis [Time frame: through 1 month]
• Number of patients with scaffold occlusion [Time frame: 6, 12, 24 and 36 months]
• Rate of Major Adverse Limb Events [Time frame: through 36 months]
• Ankle-brachial index (ABI) of target extremity [Time frame: 1, 6, 12, 24 and 36 months]
• Limb salvage of target extremity [Time frame: 1, 6, 12, 24 and 36 months]
• Rutherford-Becker Clinical Category for the target extremity [Time frame: 1, 6, 12, 24 and 36 months]
• Walking impairment as assessed by Walking Impairment Questionnaire (WIQ) [Time frame: 1, 6, 12, 24 and 36 months]

Eligibility criteria

Inclusion criteria

• Symptomatic peripheral vascular occlusive disease (Rutherford-Becker Clinical Category 2-4)
• Patient with life expectancy >36 months
• Females of childbearing potential must have negative pregnancy test
• Patient is able to provide informed consent
• Patient agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.
• Patient must be able to take antiplatelet and/or anticoagulant agents as prescribed
• Single de novo native disease segment of the superficial femoral artery (SFA) or P1 popliteal segment
• Reference vessel diameter ≥5.5 mm and ≤6.5 mm
• Target lesion length ≤90 mm
• Target lesion with ≥50% DS
• Inflow artery and popliteal artery free from flow-limiting lesion (DS <50%)

Exclusion criteria

• Hemoglobin <9.0 g/dL
• WBC <3,000 cells/mm3
• Platelet count <80,000 cells/mm3 or >700,000 cells/mm3
• Acute or chronic renal dysfunction with creatinine >2.5 mg/dl (176 µmol/L)
• Severe liver impairment as defined by total bilirubin ≥3 mg/dl or two times increase over the normal level of SGOT or SGPT
• A known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticagrelor or sirolimus, or with contrast sensitivity for which the patient cannot be adequately pre-medicated
• Patient requires a planned procedure that would necessitate discontinuation of antiplatelet therapy
• Patient is unable to walk
• Patient has undergone a percutaneous vascular intervention <30 days prior to the planned index procedure
• Patient is maintained on chronic hemodialysis
• Patient has uncontrolled diabetes mellitus (HbA1c ≥7.0%).
• Patient has had a myocardial infarction within the previous 30 days of the planned index procedure
• Patient has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limits the patient's ability to walk
• Patient has unstable angina defined as rest angina with ECG changes
• Patient has a local groin or acute systemic infection that has not been treated successfully or is currently under treatment
• Patient has acute thrombophlebitis, deep vein thrombosis or chronic venous insufficiency in either extremity
• Patient has other medical illnesses (e.g., cancer, congestive cardiomyopathy, etc.) that may cause the patient to be non-compliant with protocol requirements, confound the data interpretation or will prevent completion of all required follow up assessments through 36 months
• Patient is currently participating in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
• Patient has ischemic or neuropathic ulcers on either foot
• Patient has undergone minor or major amputation of either lower extremity
• Patient is part of a vulnerable population who, in the judgment of the Investigator, is unable to give informed consent
• Target extremity with an angiographically significant (>50% DS) lesion located distal to the target lesion that requires treatment at the time of the index procedure or by a staged procedure
• Acute arterial ischemia of the target extremity
• Target extremity has been previously treated with open surgical revascularization (bypass or endarterectomy)
• Target vessel has been previously treated with stent, laser, atherectomy, surgical bypass, or endarterectomy
• Total occlusion (100% DS) of the ipsilateral inflow artery
• Angiographic evidence of thrombus in the target vessel
• The target lesion requires treatment with a device other than percutaneous transluminal balloon angioplasty (PTA) \[e.g., orbital atherectomy, directional atherectomy, excimer laser, rotational atherectomy, cryoplasty, etc.\]
• Target lesion is within or adjacent to an aneurysm
• Patient has angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion or from crossing or pre-dilating the target lesion
• Target lesion has moderate-to-severe calcification
• Target lesion with > 30% residual stenosis following pre-dilatation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Australia · 5 centers

• Northern Health — Sydney
• Canberra Hospital — Canberra
• The Alfred Hospital — Melbourne
• Prince Of Wales Hospital — Sydney
• Royal North Shore — Sydney

New Zealand · 3 centers

• Auckland City Hospital — Auckland
• Christchurch Hospital — Christchurch
• Waikato Hospital — Hamilton

Identifiers

NCT: NCT04584632 · CL05122020

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗