Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis

Launched by BIOTRONIK AG · Aug 17, 2009

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient \>/= 18 years
• • 2. Written patient informed consent available
• • 3. Patients with stable, unstable or documented silent angina pectoris
• • 4. Patient eligible for percutaneous coronary intervention
• • 5. Patient acceptable candidate for coronary artery bypass surgery
• • 6. Patients with a single restenotic lesion in a previously stented area of a coronary artery (irrelevant whether BMS or DES related)
• • 7. Target reference vessel diameter (visual estimation): 2 - 4 mm
• • 8. Target lesion length (visual estimation): 8 - 28 mm
• • 9. Target lesion stenosis (visual estimation): \>/= 50% - \< 100%
• Exclusion Criteria:
• • 1. Left ventricular ejection fraction of \< 30%
• • 2. Visible thrombus in the target vessel visualized by angiography
• • 3. Myocardial infarction (STEMI/NSTEMI) within 72 hours of the intended treatment. Determination of CKMB and/or troponin T or I is required.
• Notes:
• • Laboratory assessments to be done within 24 hours prior to intervention. Patients with CKMB and/or troponin T or I \> 2 fold the upper limit of normal must not be included in the trial.
• • 4. Patients with planned major surgery within 3 months after planned coronary intervention and/or risk of either acetylsalicylic acid of clopidogrel cessation
• • 5. Lesion length longer than length of available treatment balloon
• • 6. Impaired renal function (serum creatinine \> 2.0mg/dl or 177 micro mol/l, determined within 72 hours prior to intervention)
• • 7. Additional coronary lesions (restenotic or de novo) in the same vessel which requires treatment
• • 8. Totally occluded coronary artery (Mehran classification IV and TIMI flow 0)
• • 9. Target lesion located in vessel bifurcation
• • 10. Previous and/or planned brachytherapy of target vessel
• • 11. Target lesion located in left main coronary artery
• • 12. Stroke or TIA \< 6 months prior to procedure
• • 13. Patient with signs of a cardiogenic shock
• • 14. Patient under ongoing systemic immunosuppressive therapy with paclitaxel or agents of the -limus group (i.e. sirolimus, tacrolimus, everolimus)
• • 15. Surgeries of any kind within 30 days prior to screening
• • 16. Patient with bleeding diathesis in whom anticoagulation or antiplatelet medication is contraindicated
• • 17. Known allergies to anti-platelet-, anticoagulation therapy, contrast media or paclitaxel
• • 18. Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required for females of child-bearing potential)
• • 19. Patient with a life expectancy of less than one year
• • 20. Patient currently enrolled in other investigational device or drug trial
• • 21. Patient with known incompliance to medical (antiplatelet, anticoagulation) therapy
• • 22. Patient not able or willing to adhere to follow-up visits including follow-up angiography