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Peripheral Arterial DiseasePhase 1NCT01007578

Drug-Eluting Balloon Catheters and the Treatment of Peripheral Arterial Occlusive Disease

A Phase 1 study testing Paclitaxel-coated balloon catheter angioplasty in people with Peripheral Arterial Disease and Stenotic Femoro-popliteal Arteries, run by Bayer at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Paclitaxel-coated balloon catheter angioplasty
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteGermany
Study dates
15 Sep 2007to 15 Dec 2007
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Herz-Zentrum Bad Krozingen

    Bad Krozingen

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
Paclitaxel-coated balloon catheter angioplasty
Keywords
Paclitaxel, Paclitaxel-coated balloon catheters, Peripheral arterial occlusive disease (PAOD), Plasma levels, Femoral artery, Popliteal artery, Peripheral arterial disease (PAD) including stenotic or occluded femoro-popliteal arteries due to atherosclerosis
Medical subject headings
Peripheral Arterial Disease, Atherosclerosis, Peripheral Arterial Occlusive Disease 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paclitaxel-coated balloon catheter angioplastyDevice

    Paclitaxel-coated balloon catheters for the treatment of peripheral arterial occlusive disease (POAD) of the femoro-popliteal arteries

Study groups in NCT01007578
Study groupRoleWhat they receive
Paclitaxel treatmentExperimentalPaclitaxel-coated balloon catheter angioplasty treated subjects
Receives: Device: Paclitaxel-coated balloon catheter angioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty at baseline

    Measured: Baseline

  2. 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

    Measured: 0.5 hours post-procedure

  3. 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

    Measured: 1 hour post-procedure

  4. 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

    Measured: 2 hours post-procedure

  5. 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

    Measured: 4 hours post-procedure

  6. 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

    Measured: 8 hours post-procedure

  7. 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

    Measured: 1 week post-procedure

  8. 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

    Measured: 2 weeks post-procedure

  9. 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

    Measured: 3 weeks post-procedure

  10. 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

    Measured: 4 weeks post-procedure

Secondary outcomes (10)

  1. Changes in blood cell counts as measure of safety at baseline

    Measured: Baseline

  2. Changes in blood cell counts as measure of safety 0.5, 1, 2, 4, 8 and 24 hours post-procedure

    Measured: 0.5, 1, 2, 4, 8 and 24 hours post-procedure

  3. Changes in blood cell counts as measure of safety 1, 2, 3, and 4 weeks post-procedure

    Measured: 1, 2, 3, and 4 weeks post-procedure

  4. Changes in serum biochemistry parameters as measure of safety at baseline

    Measured: Baseline

  5. Changes in serum biochemistry parameters as measure of safety 0.5, 1, 2, 4, 8 and 24 hours post-procedure

    Measured: 0.5, 1, 2, 4, 8 and 24 hours post-procedure

  6. Changes in serum biochemistry parameters as measure of safety 1, 2, 3, and 4 weeks post-procedure

    Measured: 1, 2, 3, and 4 weeks post-procedure

  7. Number of participants with adverse events (AEs) as a measure of safety

    Measured: From randomization until end of study, up to 4 months

  8. Number of participants with serious adverse events (SAEs) as a measure of safety

    Measured: From randomization until end of study, up to 4 months

  9. Number of participants with adverse device effects (ADEs) as a measure of safety

    Measured: From randomization until end of study, up to 4 months

  10. 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

    Measured: From randomization until end of study, up to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2009 (estimated)
  2. Study start15 Sep 2007
  3. Primary completion15 Dec 2007
  4. Study completion15 Dec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01007578
Sponsor's protocol ID
NT-4601-900
Status last verified
Sep 2023
First submitted
3 Nov 2009
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Paclitaxel-coated balloon catheter angioplasty in people with Peripheral Arterial Disease and Stenotic Femoro-popliteal Arteries, run by Bayer at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01007578.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

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