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New treatment option for Peripheral Arterial Disease
Official title The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
ClinicalTrials.gov ID: NCT04584632
What this study is testing
- What it's testing
- To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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.
You likely can't join if
- Hemoglobin \<9.0 g/dL
- WBC \<3,000 cells/mm3
- Platelet count \ 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...
See the full eligibility 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%)
- Hemoglobin \<9.0 g/dL
- WBC \<3,000 cells/mm3
- Platelet count \ 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Canberra, Australia
- Melbourne, Australia
- Sydney, Australia
- Auckland, New Zealand
- Christchurch, New Zealand
- Hamilton, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Canberra, Australia; Melbourne, Australia; Sydney, Australia; Auckland, New Zealand; Christchurch, New Zealand and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.