AzTrials
AzTrials

Coronary DiseaseDEBSIDENCT01485081

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

A study testing Danubio paclitaxel-eluting balloon in people with Coronary Disease, run by MINVASYS at 7 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Disease
What is being tested?
Danubio paclitaxel-eluting balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
7 sitesFrance
Study dates
May 2012to Jul 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 18Show fewer
  • 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.
  • The patient is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergent coronary artery bypass graft (CABG) surgery.
  • 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).
  • The patient agrees to return to the same research facility for required angiographic post-procedure follow-up visit at 6 months

Who cannot join

  • 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.
Show all 28Show fewer
  • 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).
  • Previous Percutaneous Coronary Interventions (PCI) of the target lesion.
  • Previous PCI of the target vessel within 9 months pre-procedure.
  • Planned PCI of any vessel within 30 days post-procedure.
  • Surgery 30 days prior to this PCI or anticipated surgery 6-months post this PCI.
  • 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.).
  • Second lesion requiring treatment in target vessel.
  • Second bifurcation lesion requiring treatment.
  • History of a stroke or transient ischemic attack (TIA) within the prior 6 months.
  • Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months.
  • History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Concurrent medical condition with a life expectancy of less than 12 months.
  • Any previous or planned treatment of the target vessel with anti-restenotic therapies including, but not limited to brachytherapy.
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

France7 sites

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003

  • Pôle Santé République

    Clermont-Ferrand, 63050

  • Centre Cardiologique d'Evecquemont

    Évecquemont, 78740

  • Institut hospitalier Jacques Cartier

    Massy, 91300

  • CHU Nantes

    Nantes, 44093

  • Clinique Saint-Hilaire

    Rouen, 76000

  • Clinique Pasteur

    Toulouse, 31076

Other trials in France

About this study

Official title: Assessment of 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.

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.

Read the detailed description

The DEBSIDE clinical trial is a prospective, non-randomized, multicenter, interventional study evaluating the investigational Danubio Paclitaxel Eluting Coronary Balloon for the treatment of Side Branches (SB) of de novo bifurcation lesions with a side branch reference vessel diameter ≥2.0 mm and ≤3.0 mm. During the procedure, a dedicated drug-eluting bifurcated stent will be implanted in the main branch. The trial will allow the treatment of lesion of all Medina type except (0,0,1) in native coronary arteries with sequential predilatation of the main and side branch.

The DEBSIDE clinical trial will enroll 60 patients. All patients will receive Quantitative Coronary Angiography (QCA) before and after Drug-Eluting Balloon (DEB) inflation and at 6 months follow-up. All patients will have a clinical follow-up at 1, 6 and 12 months.

Being tested
Danubio paclitaxel-eluting balloon
Keywords
Bifurcation, Drug-eluting balloon, Paclitaxel-eluting balloon, Angioplasty, Coronary artery disease, Coronary artery stenosis
Medical subject headings
Coronary Disease, Coronary Artery Disease, Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Danubio paclitaxel-eluting balloonDevice

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

Study groups in NCT01485081
Study groupRoleWhat they receive
DanubioExperimentalNot described
Receives: Device: Danubio paclitaxel-eluting balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 6 months post-procedure (up to 26 weeks)

Secondary outcomes (7)

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

    In-stent Late Lumen Loss in the MB by QCA.

    Measured: 6 months post-procedure (up to 26 weeks)

  2. Angiographic Binary Restenosis rate (%)

    Angiographic binary restenosis rate (%) in the side and main branches by QCA.

    Measured: 6 months post-procedure (up to 26 weeks)

  3. Major Adverse Cardiac Event (MACE) rate

    MACE defined as death, Myocardial Infarction (MI, Q waves and non-Q waves), emergent cardiac bypass surgery, or any target lesion revascularization (repeat Percutaneous transluminal coronary angioplasty (PTCA) or Coronary artery bypass grafting (CABG)).

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

  4. Clinically-driven Target Lesion Revascularization (TLR)

    Measured: 1, 6 and 12 months post-procedure

  5. Target Vessel Failure (TVF)

    Measured: 1, 6 and 12 months post-procedure

  6. Target Vessel Revascularization (TVR)

    Measured: 1, 6 and 12 months post-procedure

  7. Angiographic success

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2011 (estimated)
  2. Study startMay 2012
  3. Primary completionJul 2013
  4. Study completionJul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01485081
Sponsor's protocol ID
MIN1101
Acronym
DEBSIDE
Status last verified
Nov 2013
First submitted
14 Nov 2011
Last updated
8 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26696455

Questions about this trial

What is this clinical trial studying?

A study testing Danubio paclitaxel-eluting balloon in people with Coronary Disease, run by MINVASYS at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Late Lumen Loss (mm) in Side Branche (SB) (time frame: 6 months post-procedure (up to 26 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01485081, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in