Peripheral Arterial DiseasePhase 1NCT03148808
Natural Vascular Scaffold (NVS) Therapy
A Phase 1 study testing NVS Therapy in people with Peripheral Arterial Disease and Peripheral Vascular Diseases, run by Alucent Biomedical at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Peripheral Vascular Diseases, Catheterization, Peripheral
- What is being tested?
- NVS Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 May 2017to 29 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
OhioHealth Research Institute
Columbus, Ohio, 43214
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
About this study
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)
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.
Read the 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.
- Being tested
- NVS Therapy
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVS TherapyCombination product
Also called Natural Vascular Scaffold 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.
| Study group | Role | What they receive |
|---|---|---|
| NVS Therapy | Experimental | 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. Receives: Combination Product: NVS Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start25 May 2017
- Primary completion29 Oct 2018
- Study completion29 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alucent Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Ansel, MD, Principal investigator, OhioHealth Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148808
- Sponsor's protocol ID
- Protocol No.: 1060-001
- Status last verified
- Nov 2018
- First submitted
- 4 May 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03148808
- Acronym / sponsor ID
- Protocol No.: 1060-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Alucent BiomedicalIndustry (pharma, biotech, devices)
- Study start
- 25 May 2017 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| NVS Therapy | Experimental | Combination Product: NVS TherapyNVS 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NVS TherapyAlso: Natural Vascular Scaffold TherapyCombination Product: NVS Therapy which includes NVS Injection (investigational product) and the following investigational devices: NVS Delivery Catheter, NVS Light Fiber, and NVS Light Source. | Combination product | NVS Therapy |
Primary outcome
Freedom from all-cause mortality, target limb major amputation, and target lesion revascularization based on clinical observations
Time frame: Day 30
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Ansel, MD principal investigator
OhioHealth Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NVS Therapy in people with Peripheral Arterial Disease and Peripheral Vascular Diseases, run by Alucent Biomedical at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from all-cause mortality, target limb major amputation, and target lesion revascularization based on clinical observations (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018.