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Natural Vascular Scaffold (NVS) Therapy for Treatment of Atherosclerotic Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04188262
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Alucent Biomedical

Brief Summary:
The NVS Therapy is being studied to evaluate the safety and efficacy to facilitate retention of acute luminal gain, leading to acute hemodynamic improvement in superficial femoral and popliteal arteries with reference vessel diameters between 4.0 and 7.0 mm and lesion lengths less than or equal to 56mm.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Peripheral Vascular Diseases Catheterization, Peripheral Combination Product: NVS Therapy Phase 1

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 to applying NVS therapy to de novo lesions in the superficial femoral artery (SFA) and the 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 with the NVS therapy. Study Data will be analyzed through the Day 365 follow-up visit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Natural Vascular Scaffolding (NVS) Therapy for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: NVS Therapy
NVS Therapy will be delivered to de novo lesions in Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) during PTA in patients with symptomatic peripheral artery disease.
Combination Product: NVS Therapy
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.
Other Name: Natural Vascular Scaffold




Primary Outcome Measures :
  1. Freedom from all-cause mortality, freedom from target limb major amputation, freedom from target lesion revascularization (TLR). [ Time Frame: Day 30 ]
    The overall composite occurrence of participants free from all-cause mortality, target limb major amputation, target lesion revascularization (TLR) through post-index procedure Day 30 will be summarized as a percentage.

  2. NVS Drug Plasma Concentrations [ Time Frame: Day 1 - 24 (Or Discharge) ]
    The Peak Plasma Concentration (Cmax) will be determined from plasma 10-8-10 Dimer concentrations for blood samples collected.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General Description of Subject Population: Adults with symptoms of claudication and/or rest pain (Rutherford Classification 2, 3, or 4) (see Appendix 3) and angiographic evidence of an atherosclerotic lesion of the superficial femoral artery and/or proximal popliteal artery ≥70% diameter stenosis and < 100% stenosis.

Subjects must meet all of the following general eligibility criteria:

  1. Subject is at least 18 years of age.
  2. Subject (or legally authorized representative [LAR]) understands the study requirements and the treatment procedure and provides written informed consent before any study-specific tests or procedures are performed.
  3. Subject is eligible for PTA.
  4. Subject is willing to comply with all protocol required follow-up evaluations.
  5. Subject has documented Rutherford Classification 2 to 4 (see Appendix 3).
  6. Subject has laboratory test results that are within clinically acceptable limits.
  7. In investigator's opinion, subject is hemodynamically stable at the time of the index procedure.
  8. Subject has a life expectancy of ≥ 1 year in the opinion of the Investigator.
  9. Subject is able to tolerate the insertion of a 7F sheath into the common femoral artery (CFA), as determined by the investigator.
  10. Subject is able to undergo contralateral access, as determined by the Investigator.

Exclusion Criteria:

Subjects must not meet any of the following general eligibility criteria:

  1. Subject had cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months prior to enrollment with any residual deficit involving the index lower extremity.
  2. Subject has any permanent neurologic defect that may impair ambulation and/or cause non-compliance with the protocol.
  3. Subject had a STEMI or NSTEMI within the last 3 months prior to enrollment.
  4. Subject is pregnant, breastfeeding, or planning to become pregnant in the next 365 days. Subjects (male and female) must agree to use effective birth control measures for duration of study.
  5. Subject is currently receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded).

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): NCT04188262


Contacts
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Contact: Lasmy Tea, MS, MPH 3852100332 ltea@alucentbiomedical.com
Contact: Henry Hauser 3857222300 hhauser@alucentbiomedical.com

Locations
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United States, Louisiana
Cardiovascular Institute of the South Recruiting
Houma, Louisiana, United States, 70360
Contact: Deanna Benoit    985-873-5613    Deanna.Benoit@cardio.com   
Contact: Stacy Montero    985-873-5040    Stacey.Montero@cardio.com   
Principal Investigator: Craig Walker, MD         
United States, Tennessee
Wellmont CVA Heart Institute Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Lisa Vines    423-230-5640    Lisa.Vines@balladhealth.org   
Contact: Terri Walker    423-230-5643    twalker@mycva.com   
Principal Investigator: Christopher Metzger, MD         
Sponsors and Collaborators
Alucent Biomedical
Investigators
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Study Director: Henry Hauser Alucent Biomedical
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Responsible Party: Alucent Biomedical
ClinicalTrials.gov Identifier: NCT04188262    
Other Study ID Numbers: 1060-002
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases