Phase II/III randomized controlled open-label trial to evaluate the efficacy and safety of personalized tissue engineered veins in patients with chronic venous insufficiency

Conditions

Chronic Venous Insufficiency

Brief summary

Valve competency at 6 months post P-TEV implantation vs control (using Color Duplex Ultrasound to measure reflux), rVCSS score reduction at 6 months post implantation vs control (using the rVCCS)

Detailed description

Valve competency at 1, 3, 6, 12 months post-implantation vs pre-implantation (Color Duplex Ultrasound), Change in hemodynamics / reflux time at 1, 3, 6, 12 months post-implantation vs pre-implantation (Color Duplex Ultrasound), Relief of clinical signs and symptoms at 1, 3, 6, 12 months post-implantation vs pre-implantation (Ankle + calf circumference, VEINES-SYM, rVCSS, CEAP/Villalta score)), Ulcer healing at 1, 3, 6, 12 months post-implantation vs pre-implantation (ulcer number, location, area and depth), Vein disease related QoL (VEINES-QOL) and general health-related QoL (SF-36/6D) at 1, 3, 6, 12 months post-implantation vs pre-implantation, Product related and surgical procedure related adverse events (Safety)

Related papers

No related papers found yet.

Interventions

DRUGPersonalized Tissue Engineered Vein

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Valve competency at 6 months post P-TEV implantation vs control (using Color Duplex Ultrasound to measure reflux), rVCSS score reduction at 6 months post implantation vs control (using the rVCCS)	—

Secondary

Measure	Time frame
Valve competency at 1, 3, 6, 12 months post-implantation vs pre-implantation (Color Duplex Ultrasound), Change in hemodynamics / reflux time at 1, 3, 6, 12 months post-implantation vs pre-implantation (Color Duplex Ultrasound), Relief of clinical signs and symptoms at 1, 3, 6, 12 months post-implantation vs pre-implantation (Ankle + calf circumference, VEINES-SYM, rVCSS, CEAP/Villalta score)), Ulcer healing at 1, 3, 6, 12 months post-implantation vs pre-implantation (ulcer number, location, area and depth), Vein disease related QoL (VEINES-QOL) and general health-related QoL (SF-36/6D) at 1, 3, 6, 12 months post-implantation vs pre-implantation, Product related and surgical procedure related adverse events (Safety)	—

Measure

Time frame

Valve competency at 1, 3, 6, 12 months post-implantation vs pre-implantation (Color Duplex Ultrasound), Change in hemodynamics / reflux time at 1, 3, 6, 12 months post-implantation vs pre-implantation (Color Duplex Ultrasound), Relief of clinical signs and symptoms at 1, 3, 6, 12 months post-implantation vs pre-implantation (Ankle + calf circumference, VEINES-SYM, rVCSS, CEAP/Villalta score)), Ulcer healing at 1, 3, 6, 12 months post-implantation vs pre-implantation (ulcer number, location, area and depth), Vein disease related QoL (VEINES-QOL) and general health-related QoL (SF-36/6D) at 1, 3, 6, 12 months post-implantation vs pre-implantation, Product related and surgical procedure related adverse events (Safety)

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Outcome results

None listed