Clinical trial NCT03148808: Natural Vascular Scaffold (NVS) Therapy
Official title: Natural Vascular Scaffold (NVS) Therapy for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peripheral Arterial Disease
Peripheral Vascular Diseases
Catheterization, Peripheral
Lead sponsor: Alucent Biomedical
Sponsor class: INDUSTRY
First posted: 2017-05-11
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: NVS Therapy will be delivered to de novo lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) during PTA in patients with symptomatic peripheral artery disease.
Primary purpose: TREATMENT

Brief summary: The NVS Therapy is being studied to evaluate the safety and efficacy of retention of acute luminal gain, leading to acute hemodynamic improvement in superficial femoral and popliteal arteries with reference vessel diameters between 3.5 and 7.0 mm and lesion lengths between 36 and 96mm. The system is intended for use in patients with de novo lesions in the superficial femoral and proximal popliteal arteries.

Detailed description: This is a prospective, non-randomized, multi-center, open label Phase 1 study to assess the safety, pharmacokinetics (PK), and preliminary efficacy trends of applying NVS Therapy to de novo lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) during percutaneous transluminal angioplasty (PTA) in patients with life-style limiting claudication due to obstructive SFA and proximal popliteal artery atherosclerosis. Each investigator will receive supervised training for each procedure.

Eligibility to participate in the study is determined during the screening period and prior to the index procedure. Once a subject has been determined to be suitable for a peripheral intervention and all general eligibility criteria are met, angiographic eligibility will be evaluated at the time of the index procedure. Subjects then undergo the procedure with the NVS Therapy. Study data will be analyzed through the Day 365 follow-up visit.

Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age.
* Subject (or legal guardian) understands the study requirements and the treatment procedure and provides written informed consent before any study-specific tests or procedures are performed.
* Subject is eligible for PTA.
* Subject is willing to comply with all protocol required follow-up evaluations.
* Subject has documented Rutherford Classification 2 to 4 (see Appendix 3).
* Subject has laboratory test results that are within clinically acceptable limits.
* In Investigator's opinion, subject is hemodynamically stable at the time of the index procedure.
* Subject has a life expectancy of ≥1 year in the opinion of the Investigator.

Exclusion Criteria:

* Subject had cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months prior to enrollment.
* Subject has any permanent neurologic defect that may cause non-compliance with the protocol.
* Subject had an MI within last the 3 months prior to enrollment.
* Subject is pregnant, planning to become pregnant, breastfeeding or planning to breastfeed in the next 365 days.
* Subject is currently receiving oral or intravenous immunosuppressive therapy (ie, inhaled steroids are not excluded).
* Subject has known life-limiting immunosuppressive or autoimmune disease (eg, human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus).
* Subject has local or systemic thrombolytic therapy within 48 hours prior to index procedure.
* Subject is currently on oral anticoagulation therapy, such as warfarin, rivaroxaban, apixaban, or dabigatran etexilate.
* Subject has known allergies or sensitivities to heparin, aspirin (ASA), or other anticoagulant/antiplatelet therapies.
* Subject has an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
* Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding.
* Subject has documented or suspected liver disease, including laboratory evidence of hepatitis.
* Subject has renal failure or chronic kidney disease with glomerular filtration rate (GFR) ≤ 30 mL/min or Modification of Diet in Renal Disease (MDRD) study equation result of ≤ 30 mL/min per 1.73 m2.
* Subject has white blood cell (WBC) count \< (3,000 cells/mm3) within 7 days prior to index procedure.
* Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3 ≤ 7 days pre-procedure.
* Subject has been diagnosed with bleeding diatheses or hypercoagulable state.
* Subject has known or suspected active systemic infection evidenced by WBC \> 14.0 (14,000/mm3).
* Subject is currently participating in another investigational drug or device study.
* Subject intends to participate in another investigational drug or device study within 365 days after the index procedure.
* Subject has any surgical procedure or intervention performed within the 30-day period prior to index procedure.

Primary outcomes:
measure: Freedom from all-cause mortality, target limb major amputation, and target lesion revascularization based on clinical observations
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
measure: NVS Drug Plasma Concentrations
timeFrame: Day 1
Locations:
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Wynnewood
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
Study officials:
affiliation: OhioHealth Research Institute
name: Gary Ansel, MD
role: PRINCIPAL_INVESTIGATOR
References: