Paclitaxel Releasing Balloon in Patients Presenting With In-Stent Restenosis

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.

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