Natural Vascular Scaffold (NVS) Therapy

Completed · Phase 1

Conditions studied: Peripheral Arterial Disease, Peripheral Vascular Diseases, Catheterization, Peripheral

In brief

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.

Key facts

Study ID

NCT03148808

Run by

Alucent Biomedical

People needed

3

Starts

2017-05-25

Expected to finish

2018-10-29

Last updated by the study team

2018-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• OhioHealth Research Institute — Columbus, Ohio, United States
• Lankenau Institute for Medical Research — Wynnewood, Pennsylvania, United States
• Wellmont CVA Heart Institute — Kingsport, Tennessee, United States

Full record on ClinicalTrials.gov

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