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

NCT ID: NCT01007578

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-15
• Study Completion Date: 2007-12-15

Brief 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.

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.

Conditions

Peripheral Arterial Disease; Stenotic Femoro-popliteal Arteries; Occluded Femoro-popliteal Arteries; Atherosclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paclitaxel treatment

Paclitaxel-coated balloon catheter angioplasty treated subjects

Group Type: EXPERIMENTAL

Paclitaxel-coated balloon catheter angioplasty

Intervention Type: DEVICE

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

Interventions

Paclitaxel-coated balloon catheter angioplasty

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

Intervention Type: DEVICE

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Herz-Zentrum Bad Krozingen

Bad Krozingen, , Germany

Countries

Germany

Other Identifiers

NT-4601-900

Identifier Type: -

Identifier Source: org_study_id