Drug Coated Balloons for Prevention of Restenosis

NCT00696956 | Unknown Phase 2

• 1 other identifier: Pac-3
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Atherosclerosis; Restenosis; Limb Ishemia

Keywords

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)

Outcome Measures

Primary Outcomes (1)

• Primary endpoint: Late lumen loss (LLL) of the target lesion after 6 months (assessed by DSA)

  after 6 months

Secondary Outcomes (16)

• Interventional success rate (defined as reststenosis less than 50%)

  up to 18 months

• Restenosis rate at 6 and 18 months (restenosis rate is defined as a diameter stenosis of ≥ 50% of reference diameter

  up to 18 months

• Minimum lumen diameter (MLD) at 6 months

  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.

  up to 18 months

• Target vessel revascularization recorded at 6, 12 and 18 months

  up to 18 months

Study Arms (2)

A

PLACEBO COMPARATOR

Normal balloon for balloon angioplasty (Submarine, Ampherion Deep by Invatec)

Device: Balloon angioplasty (uncoated conventional balloon)

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)

Interventions

Balloon angioplasty (uncoated conventional balloon) DEVICE

endovascular therapy

A

Balloon angioplasty (conventional but coated with 3 µg/mm2 paclitaxel) DEVICE

endovascular therapy

2

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (5)

Herzzentrum Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, 76551, Germany

RECRUITING

University of Tuebingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Charite Berlin

Berlin, B, 10001, Germany

ACTIVE NOT RECRUITING

Jüdisches Krankenhaus Berlin

Berlin, B, 10001, Germany

ACTIVE NOT RECRUITING

University of Rostock

Rostock, MP, 01065, Germany

ACTIVE NOT RECRUITING

Related Publications (1)

• 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.

  PMID: 18272892 BACKGROUND

MeSH Terms

Conditions

Atherosclerosis

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Central Study Contacts

Gunnar Tepe, MD

CONTACT

49-707-129; gunnar.tepe@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 13, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 13, 2008

Record last verified: 2008-05

Locations

DE (5)