Drug Eluting Balloon for Prevention of Constrictive Remodeling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01690572
Recruitment Status : Terminated (recruitment was not sufficient.)
First Posted : September 21, 2012
Last Update Posted : April 28, 2017
Information provided by (Responsible Party):
Prof. Dr. med. Christoph Hehrlein, Herz-Zentrums Bad Krozingen

Brief Summary:
Earlier studies indicated that Percutaneous coronary intervention (PCI) may be problematic in diffuse small vessel disease especially of diabetic patients. High restenosis rates after balloon only procedures in small vessels occur due to negative constrictive vessel remodeling if DES (drug eluting stents) are not used and prolonged anti-platelet therapy is not indicated. The main hypothesis of the trial is that in analogy to DCB success in peripheral arterial disease (PAD), cellular toxicity of the drug paclitaxel eluting from a IN.PACT FalconTM DCB will prevent constrictive remodelling of small coronary vessel segments after dilatation. The IN.PACT FalconTM DCB is compared with plain old balloon angioplasty (POBA) using a Sprinter LegendTM balloon in small vessel coronary artery disease. A constrictive remodelling process will be measured by optical coherence tomography (OCT) at 9 months median F/U. This pilot trial is planned to be randomized 1:1 for DCB against POBA therapy.

Condition or disease Intervention/treatment Phase
Coronary Disease Diabetes Mellitus Device: Paclitaxel coated balloon catheter Device: uncoated balloon catheter "sprinter legend" Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Drug Coated Balloon (DCB) for the Prevention of Constrictive Remodeling and Restenosis in Small Vessel Coronary Disease
Study Start Date : October 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Paclitaxel coated balloon catheter
Paclitaxel coated balloon catheter "IN.PACT Falcon"
Device: Paclitaxel coated balloon catheter
Dilatation of the target lesion
Other Name: IN.PACT Falcon
Active Comparator: uncoated balloon catheter
uncoated balloon catheter "sprinter legend"
Device: uncoated balloon catheter "sprinter legend"
Dilatation of the target lesion
Other Name: sprinter legend

Primary Outcome Measures :
  1. MACE-rate [ Time Frame: 12 months after initial treatment ]
    combined end-point: death, myocardial infarction and revascularisation of the target lesion

Secondary Outcome Measures :
  1. OCT-measurement [ Time Frame: during follow-up, after 9 months ]
    each symptomatic patient will be examined using optical coherence tomography to detect, if the symptoms are caused by a narrowing at the target lesion

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • at least one target lesion with a stenosis severity ≥ 50% in one coronary segment with a diameter ≤ 2.5 mm
  • age > 18 years
  • weight > 45 kg
  • patient suitable for balloon dilatation and not suitable for elective implantation of a drug eluting stent
  • insulin-dependent or non-insulin-dependent diabetes mellitus
  • length of lesion ≥ 15 mm

Exclusion Criteria:

  • Life expectancy < 12 months
  • In-Stent restenosis
  • planned coronary bypass or heart valve OP
  • ST elevation myocardial infarction within the last 72 hours
  • cardiogenic shock
  • renal impairment or liver dysfunction (creatinine > 2.0 mg/dl, AST/ALT > 3x of normal value
  • incompliance
  • pregnant or breastfeeding women or women who like to be pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01690572

Department of Cardiology and Angiology I, Heart Center,
Freiburg, Baden-Württemberg, Germany, 79106
Sponsors and Collaborators
Prof. Dr. med. Christoph Hehrlein
Principal Investigator: Christoph Hehrlein, Prof. Dr. Department of Cardiology and Angiology I, Heart Center, Freiburg University

Responsible Party: Prof. Dr. med. Christoph Hehrlein, Professor Dr. med., Herz-Zentrums Bad Krozingen Identifier: NCT01690572     History of Changes
Other Study ID Numbers: DEBT
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017

Keywords provided by Prof. Dr. med. Christoph Hehrlein, Herz-Zentrums Bad Krozingen:
drug eluting balloon
constrictive remodeling

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Disease
Coronary Artery Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Albumin-Bound Paclitaxel
Hyaluronic Acid
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents