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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00961181
Study type Interventional
Source Biotronik AG
Contact
Status Completed
Phase N/A
Start date August 2009
Completion date May 2011

See also
  Status Clinical Trial Phase
Active, not recruiting NCT01835301 - Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation N/A
Completed NCT01485068 - Safety and Efficacy Study of the DANUBIO Paclitaxel Eluting Balloon in In-Stent Restenosis Lesions (DEBREST) N/A
Recruiting NCT03474432 - SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI N/A
Completed NCT01296399 - In-stent Restenosis in Patients With Patent Previous Bare Metal Stent N/A
Withdrawn NCT03008772 - REWARDS- In-stent Restenosis
Withdrawn NCT05093244 - Resveratrol Excipient Paclitaxel Coated Balloon for Coronary Treatment N/A
Active, not recruiting NCT01623180 - A Randomized Clinical Evaluation of the BioFreedomâ„¢ Stent N/A
Withdrawn NCT01411475 - Prognostic Assessment of Different Pattern of Bifurcation Restenosis