In-stent Coronary Artery Restenosis Clinical Trial
Official title:
Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis A Prospective, Multi-centre, Non-randomized Clinical Trial With Follow-up Investigations at 1, 6 and 12 Months
The primary objective of this study is to evaluate the safety and efficacy of the paclitaxel releasing balloon in patients with in-stent restenosis in a coronary artery.
All patients are treated with the paclitaxel releasing balloon Pantera Lux. The indication
is in-stent restenosis in either bare metal stent (BMS) or drug eluting stent (DES).
Clinical follow up visits at 1, 6 and 12 months. Angiographic follow up visit at 6 months.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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