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NCT04188262 · ClinicalTrials.gov registry record · Phase 1
Natural Vascular Scaffold (NVS) Therapy for Treatment of Atherosclerotic Lesions (Activate I)
A Phase 1 study of Peripheral Arterial Disease and Peripheral Vascular Diseases, sponsored by Alucent Biomedical.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 4
- Study locations
NCT04188262: Completed Phase 1 study of Peripheral Arterial Disease and Peripheral Vascular Diseases, sponsored by Alucent Biomedical.
NCT04188262 is a Phase 1 study of Peripheral Arterial Disease and Peripheral Vascular Diseases that has completed, run by Alucent Biomedical. The registered enrollment target is 9 participants, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (100% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04188262, a Phase 1 study of Peripheral Arterial Disease and Peripheral Vascular Diseases, has completed, sponsored by Alucent Biomedical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- COMBINATION_PRODUCT NVS Therapy
Study Locations (4)
Louisiana
- Cardiovascular Institute of the South - Houma
Michigan
- Mid-Michigan Heart & Vascular Center - Saginaw
North Carolina
- NC Heart & Vascular Research - Raleigh
Tennessee
- Wellmont CVA Heart Institute - Kingsport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-05-22 |
| Est. Completion | 2022-05-31 |
| Phase | Phase 1 |
What the finished NCT04188262 record still lists
NCT04188262 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 4,206-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 1 intervention - of which NVS Therapy is the first listed.
NCT04188262 reports a single indexed study location in Louisiana, Michigan, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04188262 about?
NCT04188262 is a clinical study titled "Natural Vascular Scaffold (NVS) Therapy for Treatment of Atherosclerotic Lesions (Activate I)". 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 5...
What is the current status of trial NCT04188262?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2020-05-22. Estimated completion is 2022-05-31.
What conditions does trial NCT04188262 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease, Peripheral Vascular Diseases, Catheterization, Peripheral.
What interventions are being tested in trial NCT04188262?
The interventions under investigation include: NVS Therapy (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04188262?
This trial is sponsored by Alucent Biomedical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04188262 being conducted?
This trial has 4 study locations across Louisiana, Michigan, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04188262's enrollment target sits among peer trials
9 78th of 79 higher than 2 of 79 other Peripheral Arterial Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Arterial Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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