In-stent Coronary Artery RestenosisDEBRESTNCT01485068
Safety and Efficacy Study of the DANUBIO Paclitaxel Eluting Balloon in In-Stent Restenosis Lesions (DEBREST)
A study testing Danubio paclitaxel-eluting balloon in people with In-stent Coronary Artery Restenosis, run by MINVASYS at 8 sites in France.
Trial summary
The purpose of this study is to assess safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of In-Stent Restenosis lesions in native coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-stent Coronary Artery Restenosis
- 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
- 44 participants
- Where
- 8 sitesFrance
- Study dates
- Mar 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
- Restenotic lesion in a native coronary artery.
- First ISR after BMS or DES implantation.
- Reference diameter > 2.5 and ≤ 3.5mm.
- Target lesion length: ≤ 21mm.
- Up to three restenotic lesions per patient.
- Single restenotic lesion per vessel.
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- The 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 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).
- Successful 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
- Bifurcation lesion(s) including left main.
- The Danubio covers beyond the lesion proximally and distally with < 2 mm.
- 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.
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- 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.
- Chronic total occlusion (CTO).
- A serum creatinine level > 2.0 mg/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).
- 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 restenotic lesion requiring treatment in target vessel.
- 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
8 sites in 1 country.
8 sites in 1 country
France8 sites
Hôpital Privé d'Antony
Antony, 92160
Centre Hospitalier privé Saint-Martin
Caen, 14050
Centre cardiologique d'Evecquemont
Évecquemont, 78740
Centre Hospitalier d'Haguenau
Haguenau, 67504
Les Franciscaines
Nîmes, 30000
Polyclinique les Fleurs
Ollioules, 83192
Clinique Saint-Pierre
Perpignan, 66012
Clinique Saint-Martin
Pessac, 33600
About this study
Official 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.
The purpose of this study is to assess safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of In-Stent Restenosis lesions in native coronary arteries.
Read the detailed description
The DEBREST clinical trial is a prospective, non-randomized, multicenter, interventional study evaluating the investigational Danubio Paclitaxel Eluting Coronary Balloon in patients with in-stent restenosis (ISR) lesion(s) with reference vessel diameter ≥2.5 mm and ≤3.5 mm. The trial will allow the treatment of up to two ISR (either Bare Metal Stent (BMS) or Drug Eluting Stent (DES) ISR) per patient in native coronary arteries with mandatory predilatation with a conventional balloon.
The DEBREST 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.
- Conditions
- In-stent Coronary Artery Restenosis
- Being tested
- Danubio paclitaxel-eluting balloon
- Keywords
- Restenosis, Paclitaxel-eluting balloon, Angioplasty, Coronary artery disease, Coronary artery stenosis
- Medical subject headings
- 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 in-stent restenosis lesions.
| Study group | Role | What they receive |
|---|---|---|
| Danubio | Experimental | Not described Receives: Device: Danubio paclitaxel-eluting balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent Late Lumen Loss (mm)
In-stent Late Lumen Loss by Quantitative Coronary Angiography (QCA)
Measured: 6 months post-procedure (up to 26 weeks)
Secondary outcomes (7)
In-segment Late Lumen Loss (mm)
In-segment Late Lumen Loss by QCA.
Measured: 6 months post-procedure (up to 26 weeks)
Angiographic binary restenosis rate (%)
Angiographic binary restenosis rate (%) by QCA.
Measured: 6 months post-procedure (up to 26 weeks)
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.
Clinically-driven Target Lesion Revascularization (TLR)
Measured: 1, 6 and 12 months post-procedure
Target Vessel Failure (TVF)
Measured: 1, 6 and 12 months post-procedure
Target Vessel Revascularization (TVR)
Measured: 1, 6 and 12 months post-procedure
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.
- First posted5 Dec 2011 (estimated)
- Study startMar 2012
- Primary completionJul 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-stent Coronary Artery RestenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- MINVASYS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Responsible party
- Sponsor
- Investigators
- Jacques BERLAND, MD, Principal investigator, Clinique Saint Hilaire - ROUEN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485068
- Sponsor's protocol ID
- MIN1102
- Acronym
- DEBREST
- Status last verified
- Nov 2013
- First submitted
- 14 Nov 2011
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT01485068
- Acronym / sponsor ID
- DEBREST / MIN1102
- Conditions
- In-stent Coronary Artery Restenosis
- Keywords
- Restenosis, Paclitaxel-eluting balloon, Angioplasty, Coronary artery disease, Coronary artery stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- MINVASYSIndustry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Study start
- Mar 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of In-Stent Restenosis lesions in native coronary arteries.
Detailed description
The DEBREST clinical trial is a prospective, non-randomized, multicenter, interventional study evaluating the investigational Danubio Paclitaxel Eluting Coronary Balloon in patients with in-stent restenosis (ISR) lesion(s) with reference vessel diameter ≥2.5 mm and ≤3.5 mm. The trial will allow the treatment of up to two ISR (either Bare Metal Stent (BMS) or Drug Eluting Stent (DES) ISR) per patient in native coronary arteries with mandatory predilatation with a conventional balloon.
The DEBREST 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Danubio | Experimental | Device: Danubio paclitaxel-eluting balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Restenotic lesion in a native coronary artery.
- First ISR after BMS or DES implantation.
- Reference diameter > 2.5 and ≤ 3.5mm.
- Target lesion length: ≤ 21mm.
- Up to three restenotic lesions per patient.
Key exclusion criteria (20 listed)
- Bifurcation lesion(s) including left main.
- The Danubio covers beyond the lesion proximally and distally with < 2 mm.
- Heavily calcified lesions.
- Severe tortuous lesions.
- Evidence of extensive thrombosis or dissection within target vessel before the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Danubio paclitaxel-eluting balloonInflation of the Danubio Paclitaxel Eluting Balloon in in-stent restenosis lesions. | Device | Danubio |
Primary outcome
In-stent Late Lumen Loss (mm)
Time frame: 6 months post-procedure (up to 26 weeks)
In-stent Late Lumen Loss by Quantitative Coronary Angiography (QCA)
7 secondary outcomes
In-segment Late Lumen Loss (mm)
Time frame: 6 months post-procedure (up to 26 weeks)
Angiographic binary restenosis rate (%)
Time frame: 6 months post-procedure (up to 26 weeks)
Major Adverse Cardiac Event (MACE) rate
Time frame: In-hospital, 1, 6 and 12 months post-procedure.
Clinically-driven Target Lesion Revascularization (TLR)
Time frame: 1, 6 and 12 months post-procedure
Target Vessel Failure (TVF)
Time frame: 1, 6 and 12 months post-procedure
Target Vessel Revascularization (TVR)
Time frame: 1, 6 and 12 months post-procedure
Angiographic success
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques BERLAND, MD principal investigator
Clinique Saint Hilaire - ROUEN
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Danubio paclitaxel-eluting balloon in people with In-stent Coronary Artery Restenosis, run by MINVASYS at 8 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 17 inclusion and 20 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 8 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?
In-stent Late Lumen Loss (mm) (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?
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.