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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)

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

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.

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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 2023
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine


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




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 [ Time Frame: 1, 6, 12, 24 and 36 months ]
  3. Binary restenosis [ 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. 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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04584632


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

Locations
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New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand, 1142
Contact: Andrew Holden, MD    6493670000    andrewh@adhb.govt.nz   
Sponsors and Collaborators
Efemoral Medical, Inc.
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Responsible Party: Efemoral Medical, Inc.
ClinicalTrials.gov Identifier: NCT04584632    
Other Study ID Numbers: CL05122020
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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