Drug Coated Balloons for Prevention of Restenosis

Atherosclerosis Clinical Trial

— Piccolo  

Official title:

Paclitaxel Coated Balloons for Prevention of Restenosis in Small Arteries Below the Knee Compared to Angioplasty Using Uncoated Balloons

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00696956
• Other study ID #: Pac-3
• Secondary ID: Pac-3
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 10, 2008
• Last updated: June 12, 2008
• Start date: April 2008
• Est. completion date: April 2011

Study information

• Verified date: May 2008
• Source: University Hospital Tuebingen
• Contact: Gunnar Tepe, MD
• Phone: 49-707-129
• Email: gunnar.tepe[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Limb Ishemia
• Restenosis

Intervention

Device:
• Balloon angioplasty (uncoated conventional balloon)
endovascular therapy
• Balloon angioplasty (conventional but coated with 3 µg/mm2 paclitaxel)
endovascular therapy

Locations

Country	Name	City	State
Germany	Herzzentrum Bad Krozingen	Bad Krozingen	BW
Germany	Charite Berlin	Berlin	B
Germany	Jüdisches Krankenhaus Berlin	Berlin	B
Germany	University of Rostock	Rostock	MP
Germany	University of Tuebingen	Tuebingen	BW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. doi: 10.1056/NEJMoa0706356. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint: Late lumen loss (LLL) of the target lesion after 6 months (assessed by DSA)		after 6 months	Yes
Secondary	Interventional success rate (defined as reststenosis less than 50%)		up to 18 months	No
Secondary	Restenosis rate at 6 and 18 months (restenosis rate is defined as a diameter stenosis of = 50% of reference diameter		up to 18 months	No
Secondary	Minimum lumen diameter (MLD) at 6 months		up to 18 months	Yes
Secondary	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	Yes
Secondary	Target vessel revascularization recorded at 6, 12 and 18 months		up to 18 months	Yes
Secondary	Target limb revascularization recorded at 6, 12 and 18 months		up to 18 months	Yes
Secondary	Improvement of clinical stage at 6, 12 and 18 months		up to 18 months	Yes
Secondary	Change in ABI compared to pretreatment if vessels are compressible		up to 18 months	Yes
Secondary	Hospitalization (extra days due to complications of the index procedure) and hospitalization between the follow-up visits due to the index leg		up to 18 months	Yes
Secondary	Major amputations at the index limb		up to 18 months	Yes
Secondary	Mortality		up to 18 months	Yes
Secondary	LLL of stented segments at 6 months comparing the uncoated and the coated bal-loon group.		up to 18 months	Yes
Secondary	Subgroup analysis; primary endpoint and TLR		up to 18 months	Yes
Secondary	LLL, MLD and restenosis rate at 18 month follow-up determined by angiography		up to 18 months	Yes
Secondary	Subgroup analysis neuropathy and no neuropathy according to clinical improve-ment in patients classified Rutherford 5		up to 18 months	Yes
Secondary	Clinical benefit patients Rutherford 3 vs. Rutherford 4 and 5		up to 18 months	Yes