Trials / Completed
CompletedNCT03148808
Natural Vascular Scaffold (NVS) Therapy
Natural Vascular Scaffold (NVS) Therapy for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Alucent Biomedical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-05-25
- Primary completion
- 2018-10-29
- Completion
- 2018-10-29
- First posted
- 2017-05-11
- Last updated
- 2018-11-14
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03148808. Inclusion in this directory is not an endorsement.