A novel constrained, paclitaxel-coated angioplasty balloon catheter.
EuroIntervention
; 12(17): 2140-2147, 2017 Apr 20.
Article
in En
| MEDLINE
| ID: mdl-27973329
ABSTRACT
AIMS:
The study aimed to assess drug adherence, transfer to the vessel wall, tolerance and efficacy of a constrained angioplasty balloon coated with an excipient-enhanced paclitaxel coating (Chocolate coated balloon [CCB]) in the porcine model. METHODS ANDRESULTS:
Drug adherence was investigated in vitro. Drug transfer was evaluated in porcine arteries. A stent overstretch model was chosen to provoke intimal thickening in the efficacy and tolerance study. Conventional uncoated balloons were used as controls. CCB were coated with a nominal (3 µg/mm2) and high dose (two completely overlapping inflations each at 6 µg/mm2) of paclitaxel. Efficacy was assessed by histomorphometry and quantitative coronary angiography (QCA). Tolerance, including potential downstream effects, was assessed by myocardial function and histopathology. The CCB lost 6±12% of dose during in vitro simulated delivery to the lesion; drug transfer to the vessel wall was 14±4%. QCA and histomorphometry revealed no baseline differences between treatment groups. Thirty days after treatment, both doses of the CCB resulted in a 50% reduction in neointimal thickening of arteries relative to the uncoated balloon group. Maximum neointimal thickness was 1.12±0.36 mm for uncoated control specimens and 0.46±0.06 mm and 0.44±0.30 mm for the two CCB doses (3 and 2×6 µg/mm2), respectively. There were no device-related animal deaths or changes in left ventricular ejection fraction or device-specific myocardial histopathologies. There were no statistically significant differences between inflammatory scores among treatment groups.CONCLUSIONS:
The results demonstrate efficacy and tolerance of a mechanically unique constrained angioplasty balloon within the tested dose range of the selected paclitaxel coating in the chosen porcine preclinical model.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Angioplasty, Balloon, Coronary
/
Paclitaxel
/
Neointima
/
Antineoplastic Agents, Phytogenic
Type of study:
Evaluation_studies
/
Prognostic_studies
Limits:
Animals
Language:
En
Journal:
EuroIntervention
Journal subject:
ANGIOLOGIA
/
CARDIOLOGIA
/
TERAPEUTICA
Year:
2017
Type:
Article
Affiliation country:
Germany