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

NCT01485068 | Completed DMC

• 1 other identifier: MIN1102
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

In-stent Coronary Artery Restenosis

Keywords

Restenosis; Paclitaxel-eluting balloon; Angioplasty; Coronary artery disease; Coronary artery stenosis

Outcome Measures

Primary Outcomes (1)

• In-stent Late Lumen Loss (mm)

  In-stent Late Lumen Loss by Quantitative Coronary Angiography (QCA)

  6 months post-procedure (up to 26 weeks)

Secondary Outcomes (7)

• In-segment Late Lumen Loss (mm)

  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 in-stent restenosis lesions.

Danubio

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• MINVASYS: lead
• European Cardiovascular Research Center: collaborator

Study Sites (8)

Hôpital Privé d'Antony

Antony, 92160, France

Location

Centre Hospitalier privé Saint-Martin

Caen, 14050, France

Location

Centre cardiologique d'Evecquemont

Évecquemont, 78740, France

Location

Centre Hospitalier d'Haguenau

Haguenau, 67504, France

Location

Les Franciscaines

Nîmes, 30000, France

Location

Polyclinique les Fleurs

Ollioules, 83192, France

Location

Clinique Saint-Pierre

Perpignan, 66012, France

Location

Clinique Saint-Martin

Pessac, 33600, France

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular 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: March 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2014
• Last Updated: April 8, 2015

Record last verified: 2013-11

Locations

FR (8)