Drug Coated Balloons for Prevention of Restenosis - Full Text View

Sponsored by:	University Hospital Tuebingen
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00696956

Purpose

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
Atherosclerosis Restenosis Limb Ishemia	Device: Balloon angioplasty (uncoated conventional balloon) Device: Balloon angioplasty (conventional but coated with 3 µg/mm2 paclitaxel)	Phase II Phase III

MedlinePlus related topics: Angioplasty

Drug Information available for: Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Paclitaxel Coated Balloons for Prevention of Restenosis in Small Arteries Below the Knee Compared to Angioplasty Using Uncoated Balloons

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Interventional success rate (defined as reststenosis less than 50%) [ Time Frame: up to 18 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Minimum lumen diameter (MLD) at 6 months [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Target vessel revascularization recorded at 6, 12 and 18 months [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
Target limb revascularization recorded at 6, 12 and 18 months [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
Improvement of clinical stage at 6, 12 and 18 months [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
Change in ABI compared to pretreatment if vessels are compressible [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Major amputations at the index limb [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
Mortality [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
LLL of stented segments at 6 months comparing the uncoated and the coated bal-loon group. [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
Subgroup analysis; primary endpoint and TLR [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
LLL, MLD and restenosis rate at 18 month follow-up determined by angiography [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
Subgroup analysis neuropathy and no neuropathy according to clinical improve-ment in patients classified Rutherford 5 [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]
Clinical benefit patients Rutherford 3 vs. Rutherford 4 and 5 [ Time Frame: up to 18 months ] [ Designated as safety issue: Yes ]

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
A: Placebo Comparator Normal balloon for balloon angioplasty (Submarine, Ampherion Deep by Invatec)	Device: Balloon angioplasty (uncoated conventional balloon) endovascular therapy
2: Active Comparator 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

Eligibility

Ages Eligible for Study:	18 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696956

Contacts

Contact: Gunnar Tepe, MD

49-707-129 ext 83371

gunnar.tepe@med.uni-tuebingen.de

Locations

Germany, B
Jüdisches Krankenhaus Berlin	Active, not recruiting
Berlin, B, Germany, 10001
Charite Berlin	Active, not recruiting
Berlin, B, Germany, 10001
Germany, BW
University of Tuebingen	Recruiting
Tuebingen, BW, Germany, 72076
Contact: Gunnar Tepe, MD 49-707-129 ext 83371 gunnar.tepe@med.uni-tuebingen.de
Principal Investigator: Gunnar Tepe, MD
Herzzentrum Bad Krozingen	Recruiting
Bad Krozingen, BW, Germany, 76551
Contact: Thomas Zeller, MD thomas.zeller@herzzentrum.de
Germany, MP
University of Rostock	Active, not recruiting
Rostock, MP, Germany, 01065

Sponsors and Collaborators

University Hospital Tuebingen

More Information

Publications:

Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwälder 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.

Responsible Party:	Universtiy of Tuebingen ( Prof. Dr. med. Gunnar Tepe )
Study ID Numbers:	Pac-3, Pac-3
Study First Received:	June 10, 2008
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00696956
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United States: Institutional Review Board

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)

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Paclitaxel
Vascular Diseases
Arteriosclerosis

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators

Cardiovascular Diseases
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009