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Drug Eluting Balloon for Prevention of Constrictive Remodeling

This study is currently recruiting participants.
Verified December 2012 by Herz-Zentrums Bad Krozingen
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Christoph Hehrlein, Herz-Zentrums Bad Krozingen
ClinicalTrials.gov Identifier:
NCT01690572
First received: September 19, 2012
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Coronary Disease
Diabetes Mellitus
 Device: Paclitaxel coated balloon catheter
Device: uncoated balloon catheter "sprinter legend"

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Drug Coated Balloon (DCB) for the Prevention of Constrictive Remodeling and Restenosis in Small Vessel Coronary Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Herz-Zentrums Bad Krozingen:

Primary Outcome Measures:
  • MACE-rate [ Time Frame: 12 months after initial treatment ] [ Designated as safety issue: Yes ]
    combined end-point: death, myocardial infarction and revascularisation of the target lesion


Secondary Outcome Measures:
  • OCT-measurement [ Time Frame: during follow-up, after 9 months ] [ Designated as safety issue: No ]
    each symptomatic patient will be examined using optical coherence tomography to detect, if the symptoms are caused by a narrowing at the target lesion


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • malcompliance
  • pregnant or breastfeeding women or women who like to be pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690572

Locations
Germany
Department of Cardiology and Angiology I, Heart Center, Recruiting
Freiburg, Baden-Württemberg, Germany, 79106
Contact: Christoph Weis     0049 7641 270 77090     christoph.weis@universitaets-herzzentrum.de    
Principal Investigator: Christoph Hehrlein, Prof. Dr. med.            
Sponsors and Collaborators
Prof. Dr. med. Christoph Hehrlein
Investigators
Principal Investigator: Christoph Hehrlein, Prof. Dr. Department of Cardiology and Angiology I, Heart Center, Freiburg University
  More Information

No publications provided

Responsible Party: Prof. Dr. med. Christoph Hehrlein, Professor Dr. med., Herz-Zentrums Bad Krozingen
ClinicalTrials.gov Identifier: NCT01690572     History of Changes
Other Study ID Numbers: DEBT
Study First Received: September 19, 2012
Last Updated: December 5, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Herz-Zentrums Bad Krozingen:
drug eluting balloon
constrictive remodeling

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

ClinicalTrials.gov processed this record on June 18, 2013