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

NCT01007578 | Completed Phase 1 DMC

• 1 other identifier: NT-4601-900
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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

Outcome Measures

Primary Outcomes (10)

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

  Baseline

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (10)

• Changes in blood cell counts as measure of safety at baseline

  Baseline

• 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

• 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

• Changes in serum biochemistry parameters as measure of safety at baseline

  Baseline

• 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

Study Arms (1)

Paclitaxel treatment

EXPERIMENTAL

Paclitaxel-coated balloon catheter angioplasty treated subjects

Device: Paclitaxel-coated balloon catheter angioplasty

Interventions

Paclitaxel-coated balloon catheter angioplasty DEVICE

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

Paclitaxel treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Herz-Zentrum Bad Krozingen

Bad Krozingen, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Atherosclerosis; Peripheral Arterial Occlusive Disease 1

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 4, 2009
• Study Start: September 15, 2007
• Primary Completion: December 15, 2007
• Study Completion: December 15, 2007
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

DE (1)