Trials / Completed
CompletedNCT04188262
Natural Vascular Scaffold (NVS) Therapy for Treatment of Atherosclerotic Lesions (Activate I)
Natural Vascular Scaffolding (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
- 9 (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 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.
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.
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
- 2020-05-22
- Primary completion
- 2022-04-05
- Completion
- 2022-05-31
- First posted
- 2019-12-05
- Last updated
- 2022-07-14
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04188262. Inclusion in this directory is not an endorsement.