Drug Eluting Balloon for Prevention of Constrictive Remodeling

April 27, 2017 updated by: Prof. Dr. med. Christoph Hehrlein

Drug Coated Balloon (DCB) for the Prevention of Constrictive Remodeling and Restenosis in Small Vessel Coronary Disease

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
        • Department of Cardiology and Angiology I, Heart Center,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • sprinter legend

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACE-rate
Time Frame: 12 months after initial treatment
combined end-point: death, myocardial infarction and revascularisation of the target lesion
12 months after initial treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during follow-up, after 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. med. Christoph Hehrlein

Investigators

  • Principal Investigator: Christoph Hehrlein, Prof. Dr., Department of Cardiology and Angiology I, Heart Center, Freiburg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

September 19, 2012

First Submitted That Met QC Criteria

September 19, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 27, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEBT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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