Revascularization of Stenosed Vessels Using Optimized Treatment of Rejuveinix for Reversing Endothelial Dysfunction
- Conditions
- Critical Limb IschemiaPeripheral Arterial Disease
- Interventions
- Drug: Rejuveinix Low DoseDrug: Rejuveinix High Dose
- Registration Number
- NCT03041259
- Lead Sponsor
- Reven Pharmaceuticals, Inc.
- Brief 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
- Detailed Description
This study is a prospective, randomized, double-blind, multi-center study, comparing MAE and WIQ rates to historical controls to evaluate the safety and efficacy of Rejuveinix for the treatment of patients presenting with symptoms as defined by Rutherford categories 4, 5, or 6, and who have undergone a successful infrainguinal percutaneous intervention within the femoral, femoral-popliteal, popliteal, peroneal, and/or tibial arteries. Treatment at or below the ankle will be permitted (e.g. pedal arteries). This intervention must be successful as defined by ≤ 30% stenosis as determined by angiographic or duplex ultrasound.
Preclinical studies support that Rejuveinix has acute perfusion properties that have the potential to provide synergistic benefits to patients after undergoing current standard of care interventional procedures.
Following an endovascular intervention, in one or more target vessels/lesions, using FDA cleared technology, such as a bare metal stent, angioplasty, and/or atherectomy, patients will receive Rejuveinix as an adjunct therapy. Enrolled subjects will be assigned randomly to one of two groups. Group A will receive two 20 mL treatments of Rejuveinix per week plus one placebo treatment per week comprised of 20 mL 0.9% saline. A dye will be added to the placebo; the dye will be selected from one found in the Orange Book. Group B will receive three treatments of Rejuveinix per week. Each 20 mL treatments will be combined with 100 mL 0.9% saline and administered via intravenous (IV) injection over the course of a minimum of 30 minutes. The study trial will occur for 12 one-week cycles with a washout period of two days between each cycle (a one-week cycle will include either 2 or 3 Rejuveinix treatments depending on the randomized group). Reven will also assess results calculated on four 21-day cycles to allow for a direct comparison to preclinical results.
The goal of the study is to demonstrate Rejuveinix treatment as an adjunctive therapy is non-inferior to historical controls in terms of patient safety, as measured by MAE rates, and efficacy, as assessed by the modified WIQ.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 320
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rejuveinix Low Dose Rejuveinix Low Dose Intravenous dosing of two doses per week of Rejuveinix Rejuveinix High Dose Rejuveinix High Dose Intravenous dosing of two doses per week of Rejuveinix
- Primary Outcome Measures
Name Time Method Number of Patients with Treatment-related Major Adverse Events as Defined by Re-intervention of the Target Vessel(s), Limb Amputation or Endovascular-related Death. 84 days MAE rates compared to an objective performance criterion (historical control). MAEs are defined as re-intervention of the target vessel(s), amputation of all or part of the target limb, or endovascular-related death.
- Secondary Outcome Measures
Name Time Method Change of Walking Impairment Questionnaire Score Measured at Day 1 and Day 84 in Rejuveinix Treated Patients 84 days Walking impairment questionnaire (WIQ), measured at Week 12, Day 84 (-2 to +14 days) compared to baseline assessed Week 1, Day 1 prior to administration of RJX.