Safety and Efficacy Study of the DANUBIO Paclitaxel Eluting Balloon in Side Branches of de Novo Bifurcation Lesions (DEBSIDE)

NCT01485081 | Completed DMC

• 1 other identifier: MIN1101
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to assess the safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of side branches of de novo bifurcation lesions in native coronary arteries.

Conditions

Coronary Disease

Keywords

Bifurcation; Drug-eluting balloon; Paclitaxel-eluting balloon; Angioplasty; Coronary artery disease; Coronary artery stenosis

Outcome Measures

Primary Outcomes (1)

• Late Lumen Loss (mm) in Side Branche (SB)

  Late Lumen Loss at the ostium of the SB (within 5mm from the carina) by Quantitative Coronary Angiography (QCA).

  6 months post-procedure (up to 26 weeks)

Secondary Outcomes (7)

• In-stent Late Lumen Loss (mm) in Main Branch (MB)

  6 months post-procedure (up to 26 weeks)

• Angiographic Binary Restenosis rate (%)

  6 months post-procedure (up to 26 weeks)

• Major Adverse Cardiac Event (MACE) rate

  In-hospital, 1, 6 and 12 months post-procedure.

• Clinically-driven Target Lesion Revascularization (TLR)

  1, 6 and 12 months post-procedure

• Target Vessel Failure (TVF)

  1, 6 and 12 months post-procedure

Study Arms (1)

Danubio

EXPERIMENTAL

Device: Danubio paclitaxel-eluting balloon

Interventions

Danubio paclitaxel-eluting balloon DEVICE

Inflation of the Danubio Paclitaxel Eluting Balloon in the side branch of a de novo bifurcation lesion.

Danubio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• De novo bifurcation lesions following the Medina classification except (0,0,1).
• Reference diameter main branch \>= 2.5 and ≤ 3.5 mm and side branch \>= 2.0 and ≤ 3.0 mm.
• Main branch lesion length ≤ 26mm and side branch lesion ≤ 6mm.
• For a 24mm stent in the main branch: main branch lesion length ≤ 14mm proximal and ≤ 12mm distal to the carina.
• For a 18mm stent in the main branch: main branch lesion length ≤ 8mm proximal and ≤ 12mm distal to the carina.
• Indeed an additional stent (Amazonia PAX 8mm) can be overlapped distally with the Nile PAX if a target lesion segment ≤4mm remains uncovered after implantation of the bifurcated stent.
• Maximum two bifurcation lesions per patient on two different vessels with at least one lesion treated with the procedure described on the protocol (involving the Danubio).
• The side branch of the bifurcation involving the target lesion must be treated with the trial device (Danubio).
• During the index procedure, in case of:
• Treatment of a lesion in a vessel other than the target vessel or,
• Treatment of a lesion in the target vessel distal to the target bifurcation 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).
• Successful sequential main branch and side branch predilatation with a conventional balloon providing good angiographic result (i.e. absence of dissection, TIMI \> III).
• The patient is at least 18 years of age.
• Non menopausal women must provide a negative pregnancy test and use a double contraception until the end of the study.
• The patient has clinical evidence of ischemic heart disease, stable or unstable angina with signs of ischemia, silent ischemia, or a positive functional test.

You may not qualify if:

• De novo bifurcation lesion Medina (0,0,1).
• Left main bifurcation.
• The Danubio covers beyond the side branch lesion distally with \<2mm.
• The stent covers beyond the main branch lesion proximally and distally with \<2mm.
• Heavily calcified lesions.
• Severe tortuous lesions.
• Evidence of extensive thrombosis or dissection within target vessel before the intervention
• Documented left ventricular ejection fraction (LVEF) \<30% at most recent evaluation.
• Main branch of the target lesion stented with other device than Nile PAX.
• Dissection or required additional treatment in the main or side branch of the target lesion after main branch stent implantation.
• Untreated significant lesion \>50% diameter stenosis remaining proximal or distal to the target lesion
• A known hypersensitivity or contraindication to aspirin, heparin or bivaluridin, ticlopidine or clopidogrel, paclitaxel or drugs in similar class, cobalt chromium alloys, contrast media, which cannot be adequately pre-medicated.
• Chronic total occlusion (CTO).
• A serum creatinine level \>2.0mg/dL within seven days prior to index procedure.
• Evidence of an acute MI within 72 hours of the intended index procedure (according to ARC definition).

Sponsors & Collaborators

• MINVASYS: lead
• European Cardiovascular Research Center: collaborator

Study Sites (7)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Pôle Santé République

Clermont-Ferrand, 63050, France

Location

Centre Cardiologique d'Evecquemont

Évecquemont, 78740, France

Location

Institut hospitalier Jacques Cartier

Massy, 91300, France

Location

CHU Nantes

Nantes, 44093, France

Location

Clinique Saint-Hilaire

Rouen, 76000, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Related Publications (1)

• Berland J, Lefevre T, Brenot P, Fajadet J, Motreff P, Guerin P, Dupouy P, Schandrin C; DEBSIDE trial investigators. DANUBIO - a new drug-eluting balloon for the treatment of side branches in bifurcation lesions: six-month angiographic follow-up results of the DEBSIDE trial. EuroIntervention. 2015 Dec;11(8):868-76. doi: 10.4244/EIJV11I8A177.

  PMID: 26696455 DERIVED

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Jacques BERLAND, MD

  Clinique Saint Hilaire - ROUEN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2011
• First Posted: December 5, 2011
• Study Start: May 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2014
• Last Updated: April 8, 2015

Record last verified: 2013-11

Locations

FR (7)