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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04584632
Ethics application status
Date submitted
30/09/2020
Date registered
14/10/2020

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
Not applicable
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04584632