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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
European Cardiovascular Research Center
Information provided by (Responsible Party):
MINVASYS
ClinicalTrials.gov Identifier:
NCT01485068
First received: November 14, 2011
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
In-stent Coronary Artery Restenosis
Device: Danubio paclitaxel-eluting balloon

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by MINVASYS:

Primary Outcome Measures:
  • In-stent Late Lumen Loss (mm) [ Time Frame: 6 months post-procedure (up to 26 weeks) ] [ Designated as safety issue: No ]
    In-stent Late Lumen Loss by Quantitative Coronary Angiography (QCA)


Secondary Outcome Measures:
  • In-segment Late Lumen Loss (mm) [ Time Frame: 6 months post-procedure (up to 26 weeks) ] [ Designated as safety issue: No ]
    In-segment Late Lumen Loss by QCA.

  • Angiographic binary restenosis rate (%) [ Time Frame: 6 months post-procedure (up to 26 weeks) ] [ Designated as safety issue: No ]
    Angiographic binary restenosis rate (%) by QCA.

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

  • Clinically-driven Target Lesion Revascularization (TLR) [ Time Frame: 1, 6 and 12 months post-procedure ] [ Designated as safety issue: Yes ]
  • Target Vessel Failure (TVF) [ Time Frame: 1, 6 and 12 months post-procedure ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization (TVR) [ Time Frame: 1, 6 and 12 months post-procedure ] [ Designated as safety issue: Yes ]
  • Angiographic success [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: March 2012
Estimated Study Completion Date: July 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Danubio Device: Danubio paclitaxel-eluting balloon
Inflation of the Danubio Paclitaxel Eluting Balloon in in-stent restenosis lesions.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485068

Locations
France
Hôpital Privé d'Antony
Antony, France, 92160
Centre Hospitalier privé Saint-Martin
Caen, France, 14050
Centre cardiologique d'Evecquemont
Evecquemont, France, 78740
Centre Hospitalier d'Haguenau
Haguenau, France, 67504
Les Franciscaines
Nîmes, France, 30000
Polyclinique les Fleurs
Ollioules, France, 83192
Clinique Saint-Pierre
Perpignan, France, 66012
Clinique Saint-Martin
Pessac, France, 33600
Sponsors and Collaborators
MINVASYS
European Cardiovascular Research Center
Investigators
Principal Investigator: Jacques BERLAND, MD Clinique Saint Hilaire - ROUEN
  More Information

No publications provided

Responsible Party: MINVASYS
ClinicalTrials.gov Identifier: NCT01485068     History of Changes
Other Study ID Numbers: MIN1102
Study First Received: November 14, 2011
Last Updated: November 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
France: Conseil National de l'Ordre des Médecins

Keywords provided by MINVASYS:
Restenosis
Paclitaxel-eluting balloon
Angioplasty
Coronary artery disease
Coronary artery stenosis

Additional relevant MeSH terms:
Coronary Restenosis
Cardiovascular Diseases
Coronary Disease
Coronary Stenosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 30, 2014