- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01007578
Drug-Eluting Balloon Catheters and the Treatment of Peripheral Arterial Occlusive Disease
September 18, 2023 updated by: Bayer
An Open-Labeled Multicenter Study to Investigate Plasma Levels and Catheter Tolerability Following Application of Paclitaxel Coated Balloon Catheter in Patients With Stenotic, or Occluded Femoro-Popliteal Arteries Due to Atherosclerosis
The purpose of this study is to determine plasma levels of paclitaxel and catheter tolerability subsequent to treating patients with peripheral arterial occlusive disease (PAOD) with paclitaxel-coated balloon catheters.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open-labeled multicenter study to investigate plasma levels and catheter tolerability following application of paclitaxel-coated balloon catheter angioplasty in patients with stenotic or occluded femoro-popliteal arteries due to atherosclerosis.
Safety will be assessed by changes in blood cell (leukocytes, neutrophils and thrombocytes) counts, and changes in serum biochemistry parameters.
Tolerability will be assessed by adverse event occurences related to the paclitaxel-coating and/or device by the investigator.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
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
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-
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Bad Krozingen, Germany
- Herz-Zentrum Bad Krozingen
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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
Description
Inclusion Criteria:
Patients must have met all of the following criteria for inclusion in the study:
- Clinically stable patients with PAOD disease, Rutherford stage 1, 2, 3, 4, or 5.
- Occlusion up to 5 cm or a ≥70% diameter stenosis of up to 32 cm length in the Arteria (A.) femoralis superficialis or A. popliteal, documented by angiography prior to intervention.
- Age: >18 years.
- Guide wire may successfully advance across the lesion.
- Patient was eligible for an operative vascular intervention in case of complications.
- Informed consent was signed by patient after information of possible alternatives.
Women of childbearing potential must had negative results in serum pregnancy test and use a reliable method of contraception.
Exclusion Criteria:
Patients who met any of the following exclusion criteria were not included in the study:
- Previous treatment at the same location.
- Close affiliation with the investigational site; e.g., a close relative of the Investigator, dependent person (e.g., employee or student of the investigational site).
- Acutely occurring symptoms (within the last 6 weeks) with a lysis or an operation as a therapeutic option.
- Potential loss of leg due to ischemia.
- Distal blood flow over less than one lower leg blood vessel.
- Aneurysm of intended treatment blood vessel.
- Women of child bearing potential (and up to 2 years postmenopausal) without a negative pregnancy test.
- Manifest hyperthyreosis or latent hyperthyreosis without previous blocking (sodium phosphonate).
- Blood platelet count <100.000/mm^3 or >700.000/mm^3, leukocyte count <3.000/mm^3.
- Known intolerance or contra-indication to aspirin, heparin, clopidogrel, abciximab, paclitaxel, or stainless steel, and known intolerance to contrast agents which cannot be adequately pre-treated.
- Illnesses (cancer, liver diseases, myocardial insufficiency) leading to protocol deviations and a reduced life expectancy (<2 years).
- Renal insufficiency with serum creatinine over 2.0 mg/dL.
- Diabetes mellitus with additional metformin therapy.
- Significant gastrointestinal hemorrhage in the previous 6 months.
- History of hemorrhagic diathesis or coagulopathy or rejection of blood transfusions due to religious or other reasons.
- Patient who received any investigational device or combination product for the intended indication within the 30 days prior to entering this study.
- Patient who had previously participated in another study using a paclitaxel coated catheter.
- Non-compliant or incapable patients to participate in the study (patients unable to speak or understand German language), patients not willing to answer questions regarding the study via telephone, patients rejecting an electronic storage of their patient information, or imprisoned patients.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Paclitaxel treatment
Paclitaxel-coated balloon catheter angioplasty treated subjects
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Paclitaxel-coated balloon catheters for the treatment of peripheral arterial occlusive disease (POAD) of the femoro-popliteal arteries
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty at baseline
Time Frame: Baseline
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Baseline
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Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 0.5 hours post-procedure
Time Frame: 0.5 hours post-procedure
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0.5 hours post-procedure
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Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 1 hour post-procedure
Time Frame: 1 hour post-procedure
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1 hour post-procedure
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Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 2 hours post-procedure
Time Frame: 2 hours post-procedure
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2 hours post-procedure
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Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 4 hours post-procedure
Time Frame: 4 hours post-procedure
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4 hours post-procedure
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Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 8 hours post-procedure
Time Frame: 8 hours post-procedure
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8 hours post-procedure
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Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 1 week post-procedure
Time Frame: 1 week post-procedure
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1 week post-procedure
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Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 2 weeks post-procedure
Time Frame: 2 weeks post-procedure
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2 weeks post-procedure
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Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 3 weeks post-procedure
Time Frame: 3 weeks post-procedure
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3 weeks post-procedure
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Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty 4 weeks post-procedure
Time Frame: 4 weeks post-procedure
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4 weeks post-procedure
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in blood cell counts as measure of safety at baseline
Time Frame: Baseline
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Baseline
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Changes in blood cell counts as measure of safety 0.5, 1, 2, 4, 8 and 24 hours post-procedure
Time Frame: 0.5, 1, 2, 4, 8 and 24 hours post-procedure
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0.5, 1, 2, 4, 8 and 24 hours post-procedure
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Changes in blood cell counts as measure of safety 1, 2, 3, and 4 weeks post-procedure
Time Frame: 1, 2, 3, and 4 weeks post-procedure
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1, 2, 3, and 4 weeks post-procedure
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Changes in serum biochemistry parameters as measure of safety at baseline
Time Frame: Baseline
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Baseline
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Changes in serum biochemistry parameters as measure of safety 0.5, 1, 2, 4, 8 and 24 hours post-procedure
Time Frame: 0.5, 1, 2, 4, 8 and 24 hours post-procedure
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0.5, 1, 2, 4, 8 and 24 hours post-procedure
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Changes in serum biochemistry parameters as measure of safety 1, 2, 3, and 4 weeks post-procedure
Time Frame: 1, 2, 3, and 4 weeks post-procedure
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1, 2, 3, and 4 weeks post-procedure
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Number of participants with adverse events (AEs) as a measure of safety
Time Frame: From randomization until end of study, up to 4 months
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From randomization until end of study, up to 4 months
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Number of participants with serious adverse events (SAEs) as a measure of safety
Time Frame: From randomization until end of study, up to 4 months
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From randomization until end of study, up to 4 months
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Number of participants with adverse device effects (ADEs) as a measure of safety
Time Frame: From randomization until end of study, up to 4 months
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From randomization until end of study, up to 4 months
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Number of participants with adverse events (AEs) judged as possible/probable/definitely related to the paclitaxel coating and/or device by the investigator as a measure of tolerability
Time Frame: From randomization until end of study, up to 4 months
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From randomization until end of study, up to 4 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bayer Study Director, Bayer
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 (Actual)
September 15, 2007
Primary Completion (Actual)
December 15, 2007
Study Completion (Actual)
December 15, 2007
Study Registration Dates
First Submitted
November 3, 2009
First Submitted That Met QC Criteria
November 3, 2009
First Posted (Estimated)
November 4, 2009
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 18, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Arterial Occlusive Diseases
- Atherosclerosis
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- NT-4601-900
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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