Refractory angina MedDRA version: 20.0 Level: LLT Classification code 10064262 Term: Refractory angina pectoris System Organ Class: 100000011625
Conditions
Interventions
Product Name: AdsVEGF-D?N?C
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AdsVEGF-D?N?C
Other descriptive name: AdsVEGF-D?N?C
Concentration unit: Other
Concentration type: equal
Con
Sponsors
Kuopio University Hospital Heart Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent signed 2. Age > 30 but = 85 years 3. Significant angina pectoris (CCS 2-3) despite of optimal medication 4. Significant stenosis (= 60%) in coronary angiography (= 6 months) 5. 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 (=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: 1. Women in fertile age 2. Diabetes mellitus with severe complications such as proliferative diabetic retinopathy or nephropathy with renal insufficiency (see below) 3. Clinically significant anemia (hemoglobin count 12.0x109/l) or thrombocytopenia (b-thrombocyte count 160 mg/l) 6. Liver insufficiency (P-alanine aminotransferase or P-alkaline phosphatase over 2 x normal) 7. Hematuria of unknown origin 8. Severe hypertension (systolic blood pressure > 200 mmHg or diastolic blood pressure > 110 mmHg) or significant hypotension (systolic blood pressure 35) 10. Acute infection 11. Immunosuppressive medication 12. Significant impairment of left ventricular function (EF < 25%) 13. Symptomatic congestive heart failure (NYHA 3-4) 14. Hemodynamically significant (grade 3-4/4) aortic or mitral regurgitation or other heart disease needing surgery 15. Recent (< 6 weeks) acute coronary syndrome or myocardial infarction (elevated CK-MB or cardiac troponin), PCI, CABG or TIA/stroke 16. Current or suspected malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 revascularization cannot be performed. ;Secondary Objective: The study also investigates the effect of VEGF-D-therapy on myocardial perfusion, patients' symptoms, quality of life and safety of treatment.;Primary end point(s): 1. Improvement of functional capacity using 6-minute walking test 2. Improvement of symptoms assessed by Canadian Cardiovascular Society (CCS) class;Timepoint(s) of evaluation of this end point: 1. After 6 months follow-up 2. After 6 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Improvement of functional capacity using 6-minute walking test 2. Improvement of symptoms assessed by Canadian Cardiovascular Society (CCS) class 3. Increase in myocardial perfusion;Timepoint(s) of evaluation of this end point: 1. After 12 months follow-up 2. After 12 months follow-up 3. After 6 months follow-up | — |
Countries
Denmark, Finland
Contacts
Public ContactHeart Center administration
Kuopio University Hospital Heart Center
Outcome results
None listed