Clinical trial NCT02145065: First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Femoropopliteal Artery Disease
Keywords: paclitaxel coated balloon
restenosis
Femoropopliteal artery disease
Lead sponsor: Balton Sp.zo.o.
Sponsor class: INDUSTRY
Collaborators: name: American Heart of Poland
First posted: 2014-05-22
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Angiographic late lumen loss
timeFrame: 6 months
Secondary outcomes:
measure: Safety - Device related adverse events
timeFrame: 30 days, 6 months
measure: Critical limb ischemia
timeFrame: 30 days, 6 months
measure: Device Success
timeFrame: at procedure
measure: Target Lesion Revascularization
timeFrame: 6, 12, 24 months
measure: Target vessel revascularization
timeFrame: 6, 12, 24 months
measure: Primary patency of treated segment
timeFrame: 6, 12, 24 months
measure: Treated limb amputation
timeFrame: 30 days, 6 months
Other outcomes:
measure: Change in ankle-brachial index
timeFrame: pre-procedure, 3,6 and 12 months
measure: Change in Walking Impairment Questionnaire (WIQ)
timeFrame: pre procedure, 3, 6 and 12 months
measure: Flow velocity in doppler ultrasonography
timeFrame: 3, 6 and 12 months
Locations:
city: Chrzanów
country: Poland
facility: Lesser-Poland Cardiovascular Center of American Heart of Poland
Study officials:
affiliation: American Heart of Poland, Katowice, Poland
name: Przemysław Nowakowski, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: American Heart of Poland, Katowice, Poland
name: Piotr P Buszman, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
citation: Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm 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. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.
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.
citation: Nowakowski P, Uchto W, Hrycek E, Kachel M, Ludyga T, Polczyk F, Zurakowski A, Kazmierczak P, Granada JF, Nowakowska I, Kiesz RS, Milewski KP, Buszman PE, Buszman PP. Microcrystalline paclitaxel-coated balloon for revascularization of femoropopliteal artery disease: Three-year outcomes of the randomized BIOPAC trial. Vasc Med. 2021 Aug;26(4):401-408. doi: 10.1177/1358863X20988360. Epub 2021 Mar 9.