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

Completed · Phase 1

Conditions studied: Peripheral Arterial Disease, Peripheral Vascular Diseases, Catheterization, Peripheral

In brief

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.

Key facts

Study ID

NCT04188262

Run by

Alucent Biomedical

People needed

9

Starts

2020-05-22

Expected to finish

2022-05-31

Last updated by the study team

2022-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects must not meet any of the following general eligibility criteria:
• 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.
• Subject has any permanent neurologic defect that may impair ambulation and/or cause non-compliance with the protocol.
• Subject had a STEMI or NSTEMI within the last 3 months prior to enrollment.
• 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.
• Subject is currently receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded).

Where it is running

• Cardiovascular Institute of the South — Houma, Louisiana, United States
• Mid-Michigan Heart & Vascular Center — Saginaw, Michigan, United States
• NC Heart & Vascular Research — Raleigh, North Carolina, United States
• Wellmont CVA Heart Institute — Kingsport, Tennessee, United States

Full record on ClinicalTrials.gov

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