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

Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007578
• Other study ID #: NT-4601-900
• Status: Completed
• Phase: Phase 1
• Start date: September 15, 2007
• Est. completion date: December 15, 2007

Study information

• Verified date: September 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 15, 2007
• Est. primary completion date: December 15, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have met all of the following criteria for inclusion in the study:

1. Clinically stable patients with PAOD disease, Rutherford stage 1, 2, 3, 4, or 5.

2. 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.

3. Age: >18 years.

4. Guide wire may successfully advance across the lesion.

5. Patient was eligible for an operative vascular intervention in case of complications.

6. Informed consent was signed by patient after information of possible alternatives.

7. 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:

1. Previous treatment at the same location.

2. 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).

3. Acutely occurring symptoms (within the last 6 weeks) with a lysis or an operation as a therapeutic option.

4. Potential loss of leg due to ischemia.

5. Distal blood flow over less than one lower leg blood vessel.

6. Aneurysm of intended treatment blood vessel.

7. Women of child bearing potential (and up to 2 years postmenopausal) without a negative pregnancy test.

8. Manifest hyperthyreosis or latent hyperthyreosis without previous blocking (sodium phosphonate).

9. Blood platelet count <100.000/mm^3 or >700.000/mm^3, leukocyte count <3.000/mm^3.

10. 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.

11. Illnesses (cancer, liver diseases, myocardial insufficiency) leading to protocol deviations and a reduced life expectancy (<2 years).

12. Renal insufficiency with serum creatinine over 2.0 mg/dL.

13. Diabetes mellitus with additional metformin therapy.

14. Significant gastrointestinal hemorrhage in the previous 6 months.

15. History of hemorrhagic diathesis or coagulopathy or rejection of blood transfusions due to religious or other reasons.

16. Patient who received any investigational device or combination product for the intended indication within the 30 days prior to entering this study.

17. Patient who had previously participated in another study using a paclitaxel coated catheter.

18. 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.

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Atherosclerosis
• Occluded Femoro-popliteal Arteries
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Stenotic Femoro-popliteal Arteries

Intervention

Device:
• Paclitaxel-coated balloon catheter angioplasty
Paclitaxel-coated balloon catheters for the treatment of peripheral arterial occlusive disease (POAD) of the femoro-popliteal arteries

Locations

Country	Name	City	State
Germany	Herz-Zentrum Bad Krozingen	Bad Krozingen

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma levels of paclitaxel in patients with stenotic or occluded femoro-popliteal arteries following application of paclitaxel-coated balloon catheter angioplasty at baseline		Baseline
Primary	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		0.5 hours post-procedure
Primary	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		1 hour post-procedure
Primary	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		2 hours post-procedure
Primary	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		4 hours post-procedure
Primary	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		8 hours post-procedure
Primary	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		1 week post-procedure
Primary	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		2 weeks post-procedure
Primary	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		3 weeks post-procedure
Primary	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		4 weeks post-procedure
Secondary	Changes in blood cell counts as measure of safety at baseline		Baseline
Secondary	Changes in blood cell counts as measure of safety 0.5, 1, 2, 4, 8 and 24 hours post-procedure		0.5, 1, 2, 4, 8 and 24 hours post-procedure
Secondary	Changes in blood cell counts as measure of safety 1, 2, 3, and 4 weeks post-procedure		1, 2, 3, and 4 weeks post-procedure
Secondary	Changes in serum biochemistry parameters as measure of safety at baseline		Baseline
Secondary	Changes in serum biochemistry parameters as measure of safety 0.5, 1, 2, 4, 8 and 24 hours post-procedure		0.5, 1, 2, 4, 8 and 24 hours post-procedure
Secondary	Changes in serum biochemistry parameters as measure of safety 1, 2, 3, and 4 weeks post-procedure		1, 2, 3, and 4 weeks post-procedure
Secondary	Number of participants with adverse events (AEs) as a measure of safety		From randomization until end of study, up to 4 months
Secondary	Number of participants with serious adverse events (SAEs) as a measure of safety		From randomization until end of study, up to 4 months
Secondary	Number of participants with adverse device effects (ADEs) as a measure of safety		From randomization until end of study, up to 4 months
Secondary	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		From randomization until end of study, up to 4 months