Safety and Efficacy Study of the DANUBIO Paclitaxel Eluting Balloon in In-Stent Restenosis Lesions (DEBREST)

Inclusion Criteria:

1. Restenotic lesion in a native coronary artery.
2. First ISR after BMS or DES implantation.
3. Reference diameter ≥2.5 and ≤3.5mm.
4. Target lesion length: ≤21mm.
5. Up to two restenotic lesions per patient.
6. Single lesion per vessel.
7. The lesion must be treated with the trial device Danubio.
8. Treatment of a lesion in a vessel - other than restenotic lesion target vessel - must be successfully treated with a Drug-Eluting Stent before the treatment of the target lesion (residual stenosis <30%; stent well deployed; no residual dissection; normal TIMI flow; no chest pain; ECG unchanged compared to pre-procedural ECG).
9. Successful predilatation with a conventional balloon providing good angiographic result (i.e. absence of dissection, TIMI > III).
10. The patient is at least 18 years of age.
11. Women older than 60 years.
12. The patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional test.
13. The patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergent coronary artery bypass graft (CABG) surgery.
14. The patient or patient's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Ethics Committee (EC) of the respective clinical site.
15. The patient agrees to return to the same research facility for all required post-procedure follow-up visits.

Exclusion Criteria:

1. Bifurcation lesion(s) including left main.
2. The Danubio covers beyond the lesion proximally and distally with <2 mm.
3. Heavily calcified lesions.
4. Severe tortuous lesions.
5. Evidence of extensive thrombosis or dissection within target vessel before the intervention.
6. Documented Left Ventricular Ejection Fraction (LVEF) <30% at most recent evaluation.
7. Untreated significant lesion >50% diameter stenosis remaining proximal or distal to the target lesion
8. A known hypersensitivity or contraindication to aspirin, heparin or bivaluridin, ticlopidine or clopidogrel, paclitaxel or drugs in similar class, contrast media, which cannot be adequately pre-medicated.
9. Chronic total occlusion (CTO).
10. A serum creatinine level >2.0 mg/dL within seven days prior to index procedure.
11. Evidence of an acute MI within 72 hours of the intended index procedure (according to ARC definition).
12. Planned Percutaneous Coronary Interventions (PCI) of any vessel within 30 days post-procedure.
13. Surgery 30 days prior to this PCI or anticipated surgery 6-months post this PCI.
14. During the index procedure, the target lesion requires treatment with a device other than PTCA prior to use of Danubio (including but not limited to cutting balloon, any atherectomy, any laser, thrombectomy, etc.).
15. Second lesion requiring treatment in target vessel.
16. History of a stroke or transient ischemic attack (TIA) within the prior 6 months.
17. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
18. History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
19. Concurrent medical condition with a life expectancy of less than 12 months.
20. Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy.
21. Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, Intravascular ultrasound (IVUS) or other coronary artery imaging procedures