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

NCT02145065 | Completed DMC

• 1 other identifier: PAX-0314
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease; Femoropopliteal Artery Disease

Keywords

paclitaxel coated balloon; restenosis; Femoropopliteal artery disease

Outcome Measures

Primary Outcomes (1)

• Angiographic late lumen loss

  6 months

Secondary Outcomes (7)

• Safety - Device related adverse events

  30 days, 6 months

• Critical limb ischemia

  30 days, 6 months

• Device Success

  at procedure

• Target Lesion Revascularization

  6, 12, 24 months

• Target vessel revascularization

  6, 12, 24 months

Other Outcomes (3)

• Change in ankle-brachial index

  pre-procedure, 3,6 and 12 months

• Change in Walking Impairment Questionnaire (WIQ)

  pre procedure, 3, 6 and 12 months

• Flow velocity in doppler ultrasonography

  3, 6 and 12 months

Study Arms (2)

Plain Balloon Angioplasty

ACTIVE COMPARATOR

Plain Balloon Angioplasty

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

microcrystalline Paclitaxel Coated Balloon (PAK)

EXPERIMENTAL

plain balloon angioplasty followed by mcPCB dilation

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

Interventions

Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland) DRUG

microcrystalline Paclitaxel Coated Balloon (PAK)

Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland) DEVICE

Plain Balloon Angioplasty

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Balton Sp.zo.o.: lead
• American Heart of Poland: collaborator

Study Sites (1)

Lesser-Poland Cardiovascular Center of American Heart of Poland

Chrzanów, 32-500, Poland

Location

Related Publications (6)

• 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.

  PMID: 23703720 BACKGROUND

• 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

• 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.

  PMID: 18779447 BACKGROUND

• 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.

  PMID: 17101615 BACKGROUND

• 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.

  PMID: 24456716 BACKGROUND

• 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.

  PMID: 33686879 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Przemysław Nowakowski, M.D., PhD

  American Heart of Poland, Katowice, Poland

  PRINCIPAL INVESTIGATOR

• Piotr P Buszman, M.D., PhD

  American Heart of Poland, Katowice, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 22, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 7, 2018

Record last verified: 2018-08

Locations

PL (1)