Peripheral Arterial DiseaseEfemoral INCT04584632
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
A study testing Efemoral Vascular Scaffold System (EVSS) in people with Peripheral Arterial Disease and Vascular Diseases, run by Efemoral Medical, Inc. at 8 sites in 2 countries.
Trial summary
To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease, Vascular Diseases, Stenosis
- What is being tested?
- Efemoral Vascular Scaffold System (EVSS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 22 Sep 2020to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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%)
Who cannot join
- 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
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- 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
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
Australia5 sites, 5 recruiting
- Recruiting
Canberra Hospital
Canberra
Dr Gert Frahm-Jensen
- Recruiting
The Alfred Hospital
Melbourne
Dr Gerard Goh
- Recruiting
Northern Health
Sydney, New South Wales
Dr Shrikkanth Rangarajan
- Recruiting
Prince Of Wales Hospital
Sydney
Ramon Varcoe, MD
- Recruiting
Royal North Shore
Sydney
Dr Vikram Puttaswamy
New Zealand3 sites, 3 recruiting
- Recruiting
Auckland City Hospital
Auckland, 1142
Andrew Holden, MD, 6493670000, andrewh@adhb.govt.nz
- Recruiting
Christchurch Hospital
Christchurch
Ruth Benson, MD
- Recruiting
Waikato Hospital
Hamilton
Manar Khashram, MD
About this study
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
To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery
Read the 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.
- Being tested
- Efemoral Vascular Scaffold System (EVSS)
- Keywords
- Peripheral Artery Disease, Bioresorbable
- Medical subject headings
- Peripheral Arterial Disease, Vascular Diseases, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efemoral Vascular Scaffold System (EVSS)Device
Balloon-expandable, bioresorbable vascular scaffolds coated with sirolimus
| Study group | Role | What they receive |
|---|---|---|
| EVSS | Experimental | Efemoral Vascular Scaffold System (EVSS) Receives: Device: Efemoral Vascular Scaffold System (EVSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Event (MAE)
Measured: 30 days
Freedom from Binary Restenosis
Measured: 12 months
Secondary outcomes (14)
Device Success
Achievement of successful delivery and deployment of the study device(s) at the intended target lesion
Measured: Day 0
Primary patency rate
Measured: 1, 6, 12, 24 and 36 months
Binary restenosis rate
Measured: 1, 6, 12, 24 and 36 months
Target lesion revascularization (TLR)
Measured: 1, 6, 12, 24 and 36 months
Ipsilateral extremity revascularization (IER)
Measured: 1, 6, 12, 24 and 36 months
Number of patients with Scaffold thrombosis
Measured: through 1 month
Number of patients with scaffold occlusion
Measured: 6, 12, 24 and 36 months
Rate of Major Adverse Limb Events
Measured: through 36 months
Ankle-brachial index (ABI) of target extremity
Measured: 1, 6, 12, 24 and 36 months
Limb salvage of target extremity
Measured: 1, 6, 12, 24 and 36 months
Rutherford-Becker Clinical Category for the target extremity
Measured: 1, 6, 12, 24 and 36 months
Walking impairment as assessed by Walking Impairment Questionnaire (WIQ)
Measured: 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
Measured: Up to 2 days after procedure
Technical Success
Attainment of a final residual stenosis of <30% at the intended target lesion(
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start22 Sep 2020
- Primary completionMar 2028 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efemoral Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584632
- Sponsor's protocol ID
- CL05122020
- Acronym
- Efemoral I
- Status last verified
- Mar 2026
- First submitted
- 30 Sep 2020
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04584632
- Acronym / sponsor ID
- Efemoral I / CL05122020
- Keywords
- Peripheral Artery Disease, Bioresorbable
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Efemoral Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVSS | Experimental | Device: Efemoral Vascular Scaffold System (EVSS)Efemoral Vascular Scaffold System (EVSS) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efemoral Vascular Scaffold System (EVSS)Balloon-expandable, bioresorbable vascular scaffolds coated with sirolimus | Device | EVSS |
Primary outcome
Major Adverse Event (MAE)
Time frame: 30 days
Freedom from Binary Restenosis
Time frame: 12 months
14 secondary outcomes
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
Clinical Success
Time frame: Up to 2 days after procedure
Technical Success
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efemoral Vascular Scaffold System (EVSS) in people with Peripheral Arterial Disease and Vascular Diseases, run by Efemoral Medical, Inc. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lew Schwartz, MD (224-707-2601, lewis.schwartz@efemoralmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Event (MAE) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.