First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r)

Peripheral Artery Disease Clinical Trial

— PAX  

Official title:

Prospective, Pivotal, First - in Man Clinical Trial of the Safety and Efficacy of a Novel Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145065
• Other study ID #: PAX-0314
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: October 2017

Study information

• Verified date: August 2018
• Source: Balton Sp.zo.o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this pivotal, first in man study will be to evaluate safety and efficacy of the novel, microcrystalline paclitaxel coated balloon (mcPCB, PAK, Balton) in the treatment of femoropopliteal artery disease.

Description:

Although clinically effective, the manufacturing process of first generation PCB coatings contributed to inconsistent drug concentrations, particulate formations on the balloon surface and their shedding during the interventional procedures. As a consequence developments of new PCB coatings have been proposed to address consistency, uniformity, small particle drug coverage, which may potentially contribute to improved vessel healing profile and improved clinical outcomes. Nevertheless, data on the safety and efficacy of this novel coating developments in the clinical setting remain limited. Previously in the experimental model, the investigators reported that delivery of paclitaxel via a novel mcPCB resulted in low long-term tissue retention of paclitaxel, however displayed reduced neointimal proliferation and favorable healing profile. Therefore in current clinical trial the investigators will address the feasibility and safety of the mcPCB (PAK, Balton) in the treatment of femoropopliteal restenotic disease in a prospective, randomized manner when compared to plain balloon angioplasty (PBA). The efficacy analysis will be observational and evaluated post-hoc, with no prespecified criteria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age > 18 y.o.

• Claudication in Rutherford Class 1-5,

• Lesion in the femoropopliteal artery defined as >50% and < 99% diameter stenosis with length of up to 10 cm in vessel diameter of 3-7 mm

• Chronic total occlusions of length less than 100 mm

• Ability to cross the lesions with a guidewire.

Exclusion Criteria:

• Critical acute or chronic limb ischemia

• Acute coronary syndrome

• Chronic kidney disease stage III-V

• Restenotic lesion

• Femoropopliteal graft

• Known allergy to clopidogrel or aspirin

• History of stroke within past 6 months

• Age > 80 y.o.

• Life expectancy < 2 years

Related Conditions & MeSH terms

• Femoropopliteal Artery Disease
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Drug:
• Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland)

Device:
• Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland)

Locations

Country	Name	City	State
Poland	Lesser-Poland Cardiovascular Center of American Heart of Poland	Chrzanów

Sponsors (2)

Lead Sponsor	Collaborator
Balton Sp.zo.o.	American Heart of Poland

Country where clinical trial is conducted

Poland, 

References & Publications (5)

Buszman PP, Milewski K, Zurakowski A, Pajak J, Jelonek M, Gasior P, Peppas A, Tellez A, Granada JF, Buszman PE. Experimental evaluation of pharmacokinetic profile and biological effect of a novel paclitaxel microcrystalline balloon coating in the iliofemoral territory of swine. Catheter Cardiovasc Interv. 2014 Feb;83(2):325-33. doi: 10.1002/ccd.24982. Epub 2013 Oct 23. — View Citation

Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, Tepe G, Naisbitt S, Rosenfield K. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv. 2014 Jan;7(1):10-9. doi: 10.1016/j.jcin.2013.05.022. — View Citation

Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. Epub 2006 Nov 13. — View Citation

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

Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8. Erratum in: Circulation. 2008 Oct 14;118(16):e670. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in ankle-brachial index		pre-procedure, 3,6 and 12 months
Other	Change in Walking Impairment Questionnaire (WIQ)		pre procedure, 3, 6 and 12 months
Other	Flow velocity in doppler ultrasonography		3, 6 and 12 months
Primary	Angiographic late lumen loss		6 months
Secondary	Safety - Device related adverse events		30 days, 6 months
Secondary	Critical limb ischemia		30 days, 6 months
Secondary	Device Success	Successful delivery and deployment of the first inserted study device (in overlapping setting a successful delivery and deployment of the first and second study device) at the intended target lesion and successful withdrawal of the study device with attainment of final residual stenosis of less than 30% of the target lesion by quantitative vessel angiography (QVA).	at procedure
Secondary	Target Lesion Revascularization		6, 12, 24 months
Secondary	Target vessel revascularization		6, 12, 24 months
Secondary	Primary patency of treated segment		6, 12, 24 months
Secondary	Treated limb amputation		30 days, 6 months