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

• ClinicalTrials.gov Identifier: NCT04584632
• Recruitment Status: Recruiting
• First Posted: October 14, 2020
• Last Update Posted: November 13, 2023
• Sponsor: Efemoral Medical, Inc.
• Information provided by (Responsible Party): Efemoral Medical, Inc.

Tracking Information

• First Submitted Date: September 30, 2020
• First Posted Date: October 14, 2020
• Last Update Posted Date: November 13, 2023
• Actual Study Start Date: September 22, 2020
• Estimated Primary Completion Date: March 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 6, 2020)

• Major Adverse Event (MAE) [ Time Frame: 30 days ]
• Freedom from Binary Restenosis [ Time Frame: 12 months ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 31, 2022)

• Device Success [ Time Frame: Day 0 ]
  Achievement of successful delivery and deployment of the study device(s) at the intended target lesion
• 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 ]
  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
• Technical Success [ Time Frame: Day 0 ]
  Attainment of a final residual stenosis of <30% at the intended target lesion(

Original Secondary Outcome Measures (submitted: October 6, 2020)

• Device Success [ Time Frame: Day 0 ]
  Achievement of successful delivery and deployment of the study device(s) at the intended target lesion
• Primary patency [ Time Frame: 1, 6, 12, 24 and 36 months ]
• Binary restenosis [ 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 ]
• 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 ]
  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
• Technical Success [ Time Frame: Day 0 ]
  Attainment of a final residual stenosis of <30% at the intended target lesion(

Current Other Pre-specified Outcome Measures (submitted: October 6, 2020)

• Target lesion percent mean diameter stenosis [ Time Frame: Post procedure (Day 0) and 6 months ]
• Target lesion percent maximum diameter stenosis [ Time Frame: post procedure (day 0) and at 6 months ]
• Target lesion late lumen loss [ Time Frame: 6 months ]
• Ischemia-driven target lesion revascularization (IDTLR) [ Time Frame: 1, 6, 12, 24 and 36 months ]
• Amputation (minor and major) of the target extremity [ Time Frame: 1, 6, 12, 24 and 36 months ]

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief 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
• 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
• 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
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

Device: Efemoral Vascular Scaffold System (EVSS)

Balloon-expandable, bioresorbable vascular scaffolds coated with sirolimus

Study Arms

Experimental: EVSS

Efemoral Vascular Scaffold System (EVSS)

Intervention: Device: Efemoral Vascular Scaffold System (EVSS)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 6, 2020): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2025
• Estimated Primary Completion Date: March 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

Contact: Lew Schwartz, MD; 224-707-2601; lewis.schwartz@efemoralmedical.com

• Listed Location Countries: Australia, New Zealand

Administrative Information

• NCT Number: NCT04584632
• Other Study ID Numbers: CL05122020
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Efemoral Medical, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Efemoral Medical, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Efemoral Medical, Inc.
• Verification Date: November 2023