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

RECRUITING

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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Eligibility

Age eligible for study : 0 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2020-09-22

Primary completion: 2025-03-01

Study completion finish: 2025-04-01

Study type

TREATMENT

Phase

Trial ID

NCT04584632

Intervention or treatment

DEVICE: Efemoral Vascular Scaffold System (EVSS)

Conditions

• Peripheral Arterial Disease
• Vascular Diseases
• Stenosis
• Femoropopliteal Stenosis

Image related to Peripheral Arterial Disease

Condition: Peripheral Arterial Disease, Vascular Diseases and more
DEVICE: Efemoral Vascular Scaffold System (EVSS)
Sydney, Not Specified, Australia
Sponsor: Efemoral Medical, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Prince Of Wales Hospital

Research sites nearby

Select from list below to view details:

Prince Of Wales Hospital
Sydney, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: EVSS Efemoral Vascular Scaffold System (EVSS)	DEVICE: Efemoral Vascular Scaffold System (EVSS) Balloon-expandable, bioresorbable vascular scaffolds coated with sirolimus

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Major Adverse Event (MAE)	Not Specified	30 days
Freedom from Binary Restenosis	Not Specified	12 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Device Success	Achievement of successful delivery and deployment of the study device(s) at the intended target lesion	Day 0
Primary patency rate	Not Specified	1, 6, 12, 24 and 36 months
Binary restenosis rate	Not Specified	1, 6, 12, 24 and 36 months
Target lesion revascularization (TLR)	Not Specified	1, 6, 12, 24 and 36 months
Ipsilateral extremity revascularization (IER)	Not Specified	1, 6, 12, 24 and 36 months
Number of patients with Scaffold thrombosis	Not Specified	through 1 month
Number of patients with scaffold occlusion	Not Specified	6, 12, 24 and 36 months
Rate of Major Adverse Limb Events	Not Specified	through 36 months
Ankle-brachial index (ABI) of target extremity	Not Specified	1, 6, 12, 24 and 36 months
Limb salvage of target extremity	Not Specified	1, 6, 12, 24 and 36 months
Rutherford-Becker Clinical Category for the target extremity	Not Specified	1, 6, 12, 24 and 36 months
Walking impairment as assessed by Walking Impairment Questionnaire (WIQ)	Not Specified	1, 6, 12, 24 and 36 months
Clinical Success	Attainment of a final residual stenosis of \<30% using the study device(s) and/or any adjunctive device at the intended target lesion without complications	Up to 2 days after procedure
Technical Success	Attainment of a final residual stenosis of \<30% at the intended target lesion(	Day 0

Frequently Asked Questions

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References

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