Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
114 participants
INTERVENTIONAL
2008-04-30
2011-04-30
Brief Summary
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Efficacy of paclitaxel coated PTA balloons in inhibiting restenosis of below the knee arteries (late lumen loss)
Secondary objective:
Various angiographic and clinical efficacy measures, safety and tolerance of pacli-taxel coated PTA balloons in inhibiting restenosis of below the knee arteries Descriptive statistics, comparison by t-test, chi-square test for binary events 10.1 Descriptive statistics As far as applicable descriptive statistics will be applied to data and will be referring to individual changes versus baseline (predilatation or immediately postdilatation). The groups will be compared to each other testing the statistical significance of differences (p ≤ 0.05). Con-tinuous data will be expressed as mean ± standard deviation.
Categorical variables will be compared using the chi-squared test, and continuous variables will be compared using Student's t test or ANOVA analysis.
In addition to the assessment of the primary endpoint and the secondary endpoints a multi-variate analysis to investigate the influence of risk factors on the interventional outcome (interventional success, early restenosis/occlusion, LLL, stent integrity) and clinical outcomes will be performed. For this analysis the following factors will be considered: age, diabetes, neurological status (only Rutherford 5), lesion length, grade of dissection and calcification, reststenosis, number of run-off vessels, stent administration in the index lesion(s).
10.2 Estimated number of patients The primary endpoint of the study is late lumen loss (LLL) at 6 months evaluated by quantitative angiography. Because no data according this endpoint are available for both the control group and the group which will be treated with the paclitaxel coated balloon an assumption according the LLL at 6 months was made according the expectations of the principle investigator. An estimate for LLL as % of MLD in the control group is 50% and in the drug coated balloon group 30 %. The standard deviation is calculated to be 30% of LLL. A sample size of 37 patients in each group will allow the detection of a statistically significant difference (p\<0.05) with 80% power. Based on the "Below study" which enrolled patients with comparable arterial lesions in Tuebingen and the data of the Basil study, it is estimated that 35% of the patients who will be enrolled in the study will not be available for follow-up investigations in order to calculate the MLD.
In order to meet a statistical endpoint a total of 114 patients will be enrolled.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Normal balloon for balloon angioplasty (Submarine, Ampherion Deep by Invatec)
Balloon angioplasty (uncoated conventional balloon)
endovascular therapy
2
Paclitaxel coated balloon (same balloon like in the control group, but coated with 3 µg/mm2 Paclitaxel)
Balloon angioplasty (conventional but coated with 3 µg/mm2 paclitaxel)
endovascular therapy
Interventions
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Balloon angioplasty (uncoated conventional balloon)
endovascular therapy
Balloon angioplasty (conventional but coated with 3 µg/mm2 paclitaxel)
endovascular therapy
Eligibility Criteria
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Inclusion Criteria
* peripheral vascular disease, Rutherford stage 3-5, diameter stenosis ≥ 70 %, ≥ 15 -150 mm length, up to 2 vessels to be treated
Exclusion Criteria
* Acute thrombus or aneurysm in the index limb/ vessel
* Doubts in the willingness or capability of the patient to allow follow up examination
18 Years
95 Years
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Universtiy of Tuebingen
Locations
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Herzzentrum Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, Germany
University of Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Charite Berlin
Berlin, B, Germany
Jüdisches Krankenhaus Berlin
Berlin, B, Germany
University of Rostock
Rostock, MP, Germany
Countries
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Central Contacts
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Facility Contacts
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Thomas Zeller, MD
Role: primary
Gunnar Tepe, MD
Role: primary
References
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Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.
Other Identifiers
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Pac-3
Identifier Type: -
Identifier Source: secondary_id
Pac-3
Identifier Type: -
Identifier Source: org_study_id