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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 April 2015
• Main ID: NCT01485068
• Date of registration: 14/11/2011
• Prospective Registration: Yes
• Primary sponsor: MINVASYS
• Public title: Safety and Efficacy Study of the DANUBIO Paclitaxel Eluting Balloon in In-Stent Restenosis Lesions (DEBREST) DEBREST
• Scientific title: Assessment of the Safety and Efficacy of the Danubio Paclitaxel-Eluting Balloon for the Treatment of In-Stent Restenosis Lesions in Native Coronary Arteries.
• Date of first enrolment: March 2012
• Target sample size: 44
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01485068
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Jacques BERLAND, MD
• Affiliation: Clinique Saint Hilaire - ROUEN

Key inclusion & exclusion criteria

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 three restenotic lesions per patient.

6. Single restenotic lesion per vessel.

7. The lesion must be treated with the trial device Danubio.

8. During the index procedure, in case of

1. Treatment of a lesion in a vessel other than the target vessel or,

2. Treatment of a lesion in the target vessel proximal or distal to the target
restenotic lesion, The treatment of the non-target lesion must be successfully
performed 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. Non menopausal women must provide a negative pregnancy test and use a double
contraception until the end of the study.

12. The patient has clinical evidence of ischemic heart disease, stable or unstable
angina with signs of ischemia, 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).

15. The patient agrees to return to the same research facility for required angiographic
post-procedure follow-up visit at 6 months .

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. 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.

8. Chronic total occlusion (CTO).

9. A serum creatinine level > 2.0 mg/dL within seven days prior to index procedure.

10. Evidence of an acute MI within 72 hours of the intended index procedure (according to
ARC definition).

11. Planned PCI of any vessel within 30 days post-procedure.

12. Surgery 30 days prior to this PCI or anticipated surgery 6-months post this PCI.

13. 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.).

14. Second restenotic lesion requiring treatment in target vessel.

15. History of a stroke or transient ischemic attack (TIA) within the prior 6 months

16. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6
months.

17. History of bleeding diathesis or coagulopathy or will refuse blood transfusions.

18. Concurrent medical condition with a life expectancy of less than 12 months.

19. Any previous or planned treatment of the target vessel with anti-restenotic therapies
including, but not limited to brachytherapy.

20. 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, IVUS or other coronary artery
imaging procedures



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

In-stent Coronary Artery Restenosis

Intervention(s)

Device: Danubio paclitaxel-eluting balloon

Primary Outcome(s)

In-stent Late Lumen Loss (mm) [Time Frame: 6 months post-procedure (up to 26 weeks)]

Secondary Outcome(s)

Target Vessel Failure (TVF) [Time Frame: 1, 6 and 12 months post-procedure]

Angiographic binary restenosis rate (%) [Time Frame: 6 months post-procedure (up to 26 weeks)]

Angiographic success [Time Frame: Day 1]

Clinically-driven Target Lesion Revascularization (TLR) [Time Frame: 1, 6 and 12 months post-procedure]

Major Adverse Cardiac Event (MACE) rate [Time Frame: In-hospital, 1, 6 and 12 months post-procedure.]

Target Vessel Revascularization (TVR) [Time Frame: 1, 6 and 12 months post-procedure]

In-segment Late Lumen Loss (mm) [Time Frame: 6 months post-procedure (up to 26 weeks)]

Secondary ID(s)

MIN1102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

European Cardiovascular Research Center