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Natural Vascular Scaffold (NVS) Therapy

Primary Purpose

Peripheral Arterial Disease, Peripheral Vascular Diseases, Catheterization, Peripheral

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

NVS Therapy

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

OhioHealth Research Institute
Lankenau Institute for Medical Research
Wellmont CVA Heart Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NVS Therapy

Arm 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.

Outcomes

Primary Outcome Measures

Freedom from all-cause mortality, target limb major amputation, and target lesion revascularization based on clinical observations

The overall composite occurrence of participants free from from all-cause mortality, target limb major amputation, and target lesion revascularization through post-index procedure to Day 30 will be summarized as a percentage.

Secondary Outcome Measures

Full Information

NCT ID

NCT03148808

First Posted

May 4, 2017

Last Updated

November 13, 2018

Sponsor

Alucent Biomedical

1. Study Identification

Unique Protocol Identification Number

NCT03148808

Brief Title

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

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

May 25, 2017 (Actual)

Primary Completion Date

October 29, 2018 (Actual)

Study Completion Date

October 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alucent Biomedical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease, Peripheral Vascular Diseases, Catheterization, Peripheral

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NVS Therapy

Arm Type

Experimental

Arm 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.

Intervention Type

Combination Product

Intervention Name(s)

NVS Therapy

Other Intervention Name(s)

Natural Vascular Scaffold Therapy

Intervention Description

Combination Product: NVS Therapy which includes NVS Injection (investigational product) and the following investigational devices: NVS Delivery Catheter, NVS Light Fiber, and NVS Light Source.

Primary Outcome Measure Information:

Title

Freedom from all-cause mortality, target limb major amputation, and target lesion revascularization based on clinical observations

Description

Time Frame

Day 30

Other Pre-specified Outcome Measures:

Title

NVS Drug Plasma Concentrations

Description

The Peak Plasma Concentration (Cmax) will be determined from plasma 10-8-10 Dimer concentrations for blood samples collected.

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary Ansel, MD

Organizational Affiliation

OhioHealth Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

OhioHealth Research Institute

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

Facility Name

Lankenau Institute for Medical Research

City

Wynnewood

State/Province

Pennsylvania

ZIP/Postal Code

19096

Country

United States

Facility Name

Wellmont CVA Heart Institute

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Natural Vascular Scaffold (NVS) Therapy

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