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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04584632




Registration number
NCT04584632
Ethics application status
Date submitted
30/09/2020
Date registered
14/10/2020
Date last updated
13/11/2023

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
CL05122020
Universal Trial Number (UTN)
Trial acronym
Efemoral I
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Vascular Diseases 0 0
Stenosis 0 0
Femoropopliteal Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Efemoral Vascular Scaffold System (EVSS)

Experimental: EVSS - Efemoral Vascular Scaffold System (EVSS)


Treatment: Devices: Efemoral Vascular Scaffold System (EVSS)
Balloon-expandable, bioresorbable vascular scaffolds coated with sirolimus
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major Adverse Event (MAE)
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Freedom from Binary Restenosis
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
Device Success
Timepoint [1] 0 0
Day 0
Secondary outcome [2] 0 0
Primary patency rate
Timepoint [2] 0 0
1, 6, 12, 24 and 36 months
Secondary outcome [3] 0 0
Binary restenosis rate
Timepoint [3] 0 0
1, 6, 12, 24 and 36 months
Secondary outcome [4] 0 0
Target lesion revascularization (TLR)
Timepoint [4] 0 0
1, 6, 12, 24 and 36 months
Secondary outcome [5] 0 0
Ipsilateral extremity revascularization (IER)
Timepoint [5] 0 0
1, 6, 12, 24 and 36 months
Secondary outcome [6] 0 0
Number of patients with Scaffold thrombosis
Timepoint [6] 0 0
through 1 month
Secondary outcome [7] 0 0
Number of patients with scaffold occlusion
Timepoint [7] 0 0
6, 12, 24 and 36 months
Secondary outcome [8] 0 0
Rate of Major Adverse Limb Events
Timepoint [8] 0 0
through 36 months
Secondary outcome [9] 0 0
Ankle-brachial index (ABI) of target extremity
Timepoint [9] 0 0
1, 6, 12, 24 and 36 months
Secondary outcome [10] 0 0
Limb salvage of target extremity
Timepoint [10] 0 0
1, 6, 12, 24 and 36 months
Secondary outcome [11] 0 0
Rutherford-Becker Clinical Category for the target extremity
Timepoint [11] 0 0
1, 6, 12, 24 and 36 months
Secondary outcome [12] 0 0
Walking impairment as assessed by Walking Impairment Questionnaire (WIQ)
Timepoint [12] 0 0
1, 6, 12, 24 and 36 months
Secondary outcome [13] 0 0
Clinical Success
Timepoint [13] 0 0
Up to 2 days after procedure
Secondary outcome [14] 0 0
Technical Success
Timepoint [14] 0 0
Day 0

Eligibility
Key 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%)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Prince Of Wales Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Efemoral Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04584632
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lew Schwartz, MD
Address 0 0
Country 0 0
Phone 0 0
224-707-2601
Fax 0 0
Email 0 0
lewis.schwartz@efemoralmedical.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04584632