Drug Coated Balloons for Prevention of Restenosis (Piccolo)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2008 by University Hospital Tuebingen.
Recruitment status was:  Recruiting
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
First received: June 10, 2008
Last updated: June 12, 2008
Last verified: May 2008

The study will be performed as a randomized, double blind trial (in respect of the primary end point) with treatment of the stenotic lesion using uncoated PTA-catheters as control group. 114 patients will be included in the trial at about 5 study centers. Follow-up includes control angiography after 6 and 18 months and clinical follow-up examinations up to 18 months. Primary objective:

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.

Condition Intervention Phase
Limb Ishemia
Device: Balloon angioplasty (uncoated conventional balloon)
Device: Balloon angioplasty (conventional but coated with 3 µg/mm2 paclitaxel)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Paclitaxel Coated Balloons for Prevention of Restenosis in Small Arteries Below the Knee Compared to Angioplasty Using Uncoated Balloons

Resource links provided by NLM:

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Primary endpoint: Late lumen loss (LLL) of the target lesion after 6 months (assessed by DSA) [ Time Frame: after 6 months ]

Secondary Outcome Measures:
  • Interventional success rate (defined as reststenosis less than 50%) [ Time Frame: up to 18 months ]
  • Restenosis rate at 6 and 18 months (restenosis rate is defined as a diameter stenosis of ≥ 50% of reference diameter [ Time Frame: up to 18 months ]
  • Minimum lumen diameter (MLD) at 6 months [ Time Frame: up to 18 months ]
  • Target lesion revascularization recorded at 6, 12 and 18 months; target lesion revascularization is defined as any reintervention or artery bypass graft surgery involving the target lesion. [ Time Frame: up to 18 months ]
  • Target vessel revascularization recorded at 6, 12 and 18 months [ Time Frame: up to 18 months ]
  • Target limb revascularization recorded at 6, 12 and 18 months [ Time Frame: up to 18 months ]
  • Improvement of clinical stage at 6, 12 and 18 months [ Time Frame: up to 18 months ]
  • Change in ABI compared to pretreatment if vessels are compressible [ Time Frame: up to 18 months ]
  • Hospitalization (extra days due to complications of the index procedure) and hospitalization between the follow-up visits due to the index leg [ Time Frame: up to 18 months ]
  • Major amputations at the index limb [ Time Frame: up to 18 months ]
  • Mortality [ Time Frame: up to 18 months ]
  • LLL of stented segments at 6 months comparing the uncoated and the coated bal-loon group. [ Time Frame: up to 18 months ]
  • Subgroup analysis; primary endpoint and TLR [ Time Frame: up to 18 months ]
  • LLL, MLD and restenosis rate at 18 month follow-up determined by angiography [ Time Frame: up to 18 months ]
  • Subgroup analysis neuropathy and no neuropathy according to clinical improve-ment in patients classified Rutherford 5 [ Time Frame: up to 18 months ]
  • Clinical benefit patients Rutherford 3 vs. Rutherford 4 and 5 [ Time Frame: up to 18 months ]

Estimated Enrollment: 114
Study Start Date: April 2008
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
Normal balloon for balloon angioplasty (Submarine, Ampherion Deep by Invatec)
Device: Balloon angioplasty (uncoated conventional balloon)
endovascular therapy
Active Comparator: 2
Paclitaxel coated balloon (same balloon like in the control group, but coated with 3 µg/mm2 Paclitaxel)
Device: Balloon angioplasty (conventional but coated with 3 µg/mm2 paclitaxel)
endovascular therapy


Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age between 18 and 95 years,
  • peripheral vascular disease, Rutherford stage 3-5, diameter stenosis ≥ 70 %, ≥ 15 -150 mm length, up to 2 vessels to be treated

Exclusion Criteria:

  • Disease associated with life-expectancy less than 18 months
  • Acute thrombus or aneurysm in the index limb/ vessel
  • Doubts in the willingness or capability of the patient to allow follow up examination
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00696956

Herzzentrum Bad Krozingen
Bad Krozingen, BW, Germany, 76551
University of Tuebingen
Tuebingen, BW, Germany, 72076
Charite Berlin
Berlin, B, Germany, 10001
Jüdisches Krankenhaus Berlin
Berlin, B, Germany, 10001
University of Rostock
Rostock, MP, Germany, 01065
Sponsors and Collaborators
University Hospital Tuebingen
  More Information

Responsible Party: Prof. Dr. med. Gunnar Tepe, Universtiy of Tuebingen
ClinicalTrials.gov Identifier: NCT00696956     History of Changes
Other Study ID Numbers: Pac-3 
Study First Received: June 10, 2008
Last Updated: June 12, 2008

Keywords provided by University Hospital Tuebingen:
local drug delivery
balloon angioplasty
safety and tolerance of paclitaxel coated PTA balloons
in inhibiting restenosis of below the knee arteries
Efficacy of paclitaxel coated PTA balloons
in inhibiting restenosis of below the knee arteries (late lumen loss)

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on January 19, 2017