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.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease; Vascular Diseases; Stenosis; Femoropopliteal Stenosis	Device: Efemoral Vascular Scaffold System (EVSS)	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 22, 2020
• Estimated Primary Completion Date: March 2025
• Estimated Study Completion Date: April 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: EVSS; Efemoral Vascular Scaffold System (EVSS)	Device: Efemoral Vascular Scaffold System (EVSS); Balloon-expandable, bioresorbable vascular scaffolds coated with sirolimus

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Device Success [ Time Frame: Day 0 ]
   Achievement of successful delivery and deployment of the study device(s) at the intended target lesion
2. Primary patency rate [ Time Frame: 1, 6, 12, 24 and 36 months ]
3. Binary restenosis rate [ Time Frame: 1, 6, 12, 24 and 36 months ]
4. Target lesion revascularization (TLR) [ Time Frame: 1, 6, 12, 24 and 36 months ]
5. Ipsilateral extremity revascularization (IER) [ Time Frame: 1, 6, 12, 24 and 36 months ]
6. Number of patients with Scaffold thrombosis [ Time Frame: through 1 month ]
7. Number of patients with scaffold occlusion [ Time Frame: 6, 12, 24 and 36 months ]
8. Rate of Major Adverse Limb Events [ Time Frame: through 36 months ]
9. Ankle-brachial index (ABI) of target extremity [ Time Frame: 1, 6, 12, 24 and 36 months ]
10. Limb salvage of target extremity [ Time Frame: 1, 6, 12, 24 and 36 months ]
11. Rutherford-Becker Clinical Category for the target extremity [ Time Frame: 1, 6, 12, 24 and 36 months ]
12. Walking impairment as assessed by Walking Impairment Questionnaire (WIQ) [ Time Frame: 1, 6, 12, 24 and 36 months ]
13. 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
14. Technical Success [ Time Frame: Day 0 ]
    Attainment of a final residual stenosis of <30% at the intended target lesion(

Other Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

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

Locations

Australia

Prince Of Wales Hospital; Recruiting

Sydney, Australia

Contact: Ramon Varcoe, MD

New Zealand

Auckland City Hospital; Recruiting

Auckland, New Zealand, 1142

Contact: Andrew Holden, MD 6493670000 andrewh@adhb.govt.nz

Christchurch Hospital; Recruiting

Christchurch, New Zealand

Contact: Ruth Benson, MD

Waikato Hospital; Recruiting

Hamilton, New Zealand

Contact: Manar Khashram, MD

Sponsors and Collaborators

Efemoral Medical, Inc.

More Information

• Responsible Party: Efemoral Medical, Inc.
• ClinicalTrials.gov Identifier: NCT04584632
• Other Study ID Numbers: CL05122020
• First Posted: October 14, 2020
• Last Update Posted: November 13, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Efemoral Medical, Inc.:

Peripheral Artery Disease; Bioresorbable

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Vascular Diseases; Constriction, Pathologic; Pathological Conditions, Anatomical; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases