Adenovirus Vascular Endothelial Growth Factor D (AdvVEGF-D) Therapy for Treatment of Refractory Angina Pectoris

Launched by KUOPIO UNIVERSITY HOSPITAL · Jan 30, 2017

Keywords

ClinConnect Summary

Study overview:

The purpose of the study is to evaluate the safety and efficacy of catheter mediated AdVEGF-D regenerative gene transfer in patients with refractory angina to whom revascularisation cannot be performed.

Primary objectives:

To test the efficacy of the therapy to improve functional capacity using 6 minute walking test after 6 months follow-up and improvement of symptoms assessed by Canadian Cardiovascular Society (CCS) class.

Secondary objectives:

Efficacy of the gene transfer to increase to improve functional capacity using 6 minute walking test and improvement of sympto...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • informed consent signed
• • age \> 30 but \< 85 years
• • significant angina pectoris (CCS 2-3) despite of optimal medication
• • significant stenosis (\> 60%) in coronary angiography (\< 6 months)
• • contraindication to CABG or PCI due to diffuse or distal stenosis, chronic total occlusion, vessels with difficult anatomy, stenosis with severe calcifications and stenosis in small vessels (\<2.5 mm))
• • angina pectoris or equivalent symptoms in the 6-minute walking exercise test
• • left ventricle wall \> 8 mm detected by transthoracic echocardiography or magnetic resonance imaging (treatment area)
• Exclusion Criteria:
• • women in fertile age
• • diabetes mellitus with severe complications such as diabetic retinopathy or nephropathy
• • clinically significant anemia (hemoglobin count \< 120 mg/l in male, \< 110 mg/l in female; hematocrit \< 0.36), leukopenia (b-leukocyte count \< 3.0x109/l), leukocytosis (b-leukocyte count \> 12.0x109/l) or thrombocytopenia (b-thrombocyte count \< 100x109/l)
• • renal insufficiency (P-creatinine \> 160 mg/l)
• • liver insufficiency (P-alanine aminotransferase or P-alkaline phosphatase over 2 x normal)
• • haematuria of unknown origin
• • severe hypertension (systolic blood pressure \> 200 mmHg or diastolic blood pressure \> 110 mmHg) or significant hypotension (systolic blood pressure \< 90 mmHg)
• • significant obesity (Body Mass Index \> 35)
• • acute infection
• • immunosuppressive medication
• • significant impairment of left ventricular function (ejection fraction \< 25% in echocardiography)
• • symptomatic congestive heart failure (New York Heart Association class 3-4)
• • haemodynamically significant (grade 3-4/4) aortic or mitral regurgitation or other heart disease needing surgery
• • recent (\< 6 weeks) acute coronary syndrome or myocardial infarction, PCI or CABG, stroke or transient ischemic attack (TIA)
• • current or suspected malignancy