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Revascularization of Stenosed Vessels Using Optimized Treatment of Rejuveinix for Reversing Endothelial Dysfunction

NCT03041259 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2018-08-09

No results posted yet for this study

Summary

A Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of Rejuveinix in Combination With Standard Interventional Therapy for Critical Limb Ischemia Patients with Rutherford Class 4, 5 and 6 Disease

Conditions

  • Critical Limb Ischemia
  • Peripheral Arterial Disease

Interventions

DRUG

Rejuveinix Low Dose

A intravenous administration of Rejuveinix after standard mechanical intervention of blocked peripheral artery

DRUG

Rejuveinix High Dose

A intravenous administration of Rejuveinix after standard mechanical intervention of blocked peripheral artery

Sponsors & Collaborators

  • Reven Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2022-01-31
Completion
2022-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03041259 on ClinicalTrials.gov