- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01690572
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
-
-
Baden-Württemberg
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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"
|
Dilatation of the target lesion
Other Names:
|
Active Comparator: uncoated balloon catheter
uncoated balloon catheter "sprinter legend"
|
Dilatation of the target lesion
Other Names:
|
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.
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
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Coronary Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protective Agents
- Antineoplastic Agents, Phytogenic
- Adjuvants, Immunologic
- Viscosupplements
- Paclitaxel
- Hyaluronic Acid
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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