Adenovirus Vascular Endothelial Growth Factor D (AdvVEGF-D) Therapy for Treatment of Refractory A… (NCT03039751) | Clinical Trial Compass
CompletedPhase 2
Adenovirus Vascular Endothelial Growth Factor D (AdvVEGF-D) Therapy for Treatment of Refractory Angina Pectoris
Denmark, Finland63 participantsStarted 2019-10-19
Plain-language summary
The purpose of the study is to evaluate the safety and efficacy of catheter mediated endocardial adenovirus-mediated vascular endothelial growth factor-D (AdVEGF-D) regenerative gene transfer in patients with refractory angina to whom revascularisation cannot be performed.
Who can participate
Age range30 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…