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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

VeriGraft AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-04-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

VERIGRAFT

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To demonstrate the efficacy of P-TEV grafts with valves in the reduction of deep venous valve
pathology in patients with severe CVI (Disease-modifying efficacy).

To demonstrate the efficacy of P-TEV grafts with valves in the reduction of clinical signs and
symptoms of CVI in patients with severe CVI (Clinical efficacy).

Secondary objectives 2

1. To confirm the durability and efficacy of P-TEV grafts over a period of 12 months
2. To confirm the safety of P-TEV grafts for the treatment of CVI.

Conditions and MedDRA coding

Chronic Venous Insufficiency

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male or Female patients aged between 18 and 75 years old
2. CVI patients with painful swelling and/or skin changes and/or recurrent leg ulcer despite optimal conservative treatment for a period according to the Investigator’s judgement
3. Patients with significant femoral deep venous reflux
4. Lab values: INR <1.7 (patient on Warfarin, may repeat the test after anticoagulant change); Platelets ≥ 100 x 109/L; Hemoglobin ≥ 100 g/L; Total bilirubin ≤ 1.5 × upper limit of normal (ULN) o ASAT ≤ 2.5 × ULN; ALAT ≤ 2.5 × ULN; Lipid profile within acceptable range according to Investigator’s opinion; Clinical chemistry within acceptable range according to Investigator’s opinion

Exclusion criteria 23

1. Patients incapable of giving direct or representative written informed consent
2. Patients unlikely to cooperate fully in the trial and/or with anticipated poor compliance
3. Non-walking patients or patients with impaired ankle joint function
4. Patients previously organ-transplanted
5. Patients with cancer except in-situ cancer or a five-year recurrence free period after treatment
6. Patients with autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus and multiple sclerosis
7. Pregnant or breast-feeding women
8. Patients with ongoing estrogen treatment
9. Patients with a BMI ≥ 38 or a degree of obesity leading to expected difficulty in surgery or motion according to Investigator’s opinion
10. Patients who plan to participate in other clinical trials or have participated in other clinical trials during the past 3 months
11. Patients with arterial pathology (ankle-brachial pressure index < 0,9 or > 1,3)
12. Patients with thrombophilia that cannot be controlled with antithrombotic drugs
13. Patients with an active infection requiring systemic antibiotic treatment
14. Patients with clinically significant cardiac disease (NYHA Class III or IV), measured LVEF ≤ 40% or an acute cardiac event in the past 6 months
15. Patients with uncontrolled hypertension
16. Patients with renal dysfunction eGFR < 45 ml/min
17. Patients with severe hepatic impairment
18. Patients with ongoing immunosuppression, systemic Cortisol treatment etc
19. Less than 3 months since previous ipsilateral venous intervention (e.g. recanalization)
20. Clinically significant iliocaval stenosis or occlusion
21. Patients with severe SARSCoV-2 virus infection requiring hospitalization during the past 6 months
22. Patients meeting ASA (American Society of Anesthesiologists Classification) ≥ 4
23. Patients with other uncontrolled intercurrent illness that would jeopardize the patient’s safety, interfere with the objectives of the protocol, or limit the patient’s compliance with study requirements, as determined by the Investigator together with the Sponsor

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

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

Secondary endpoints 6

1. Valve competency at 1, 3, 6, 12 months post-implantation vs pre-implantation (Color Duplex Ultrasound)
2. Change in hemodynamics / reflux time at 1, 3, 6, 12 months post-implantation vs pre-implantation (Color Duplex Ultrasound)
3. 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))
4. Ulcer healing at 1, 3, 6, 12 months post-implantation vs pre-implantation (ulcer number, location, area and depth)
5. 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
6. Product related and surgical procedure related adverse events (Safety)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

VeriGraft AB

Sponsor organisation

VeriGraft AB

Address

S Annedal, Arvid Wallgrens Backe 20, Goteborgs Annedal Arvid Wallgrens Backe 20 Goteborgs Annedal

City

Goteborg

Postcode

413 46

Country

Sweden

Scientific contact point

Organisation

VeriGraft AB

Contact name

Raimund Strehl

Public contact point

Organisation

VeriGraft AB

Contact name

Petter Björquist

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications