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Peripheral Artery DiseasePAXNCT02145065

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

A study testing Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland) and Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland) in people with Peripheral Artery Disease and Femoropopliteal Artery Disease, run by Balton Sp.zo.o. at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland) and Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 sitePoland
Study dates
Sep 2014to Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • History of stroke within past 6 months
  • Age > 80 y.o.
  • Life expectancy < 2 years

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Lesser-Poland Cardiovascular Center of American Heart of Poland

    Chrzanów, 32-500

Other trials in Poland

About this study

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

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.

Read the 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.

Being tested
Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland), Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland)
Keywords
paclitaxel coated balloon, restenosis, Femoropopliteal artery disease
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT02145065
Study groupRoleWhat they receive
Plain Balloon AngioplastyActive comparatorPlain Balloon Angioplasty
Receives: Device: Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland)
microcrystalline Paclitaxel Coated Balloon (PAK)Experimentalplain balloon angioplasty followed by mcPCB dilation
Receives: Drug: Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Angiographic late lumen loss

    Measured: 6 months

Secondary outcomes (7)

  1. Safety - Device related adverse events

    Measured: 30 days, 6 months

  2. Critical limb ischemia

    Measured: 30 days, 6 months

  3. 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).

    Measured: at procedure

  4. Target Lesion Revascularization

    Measured: 6, 12, 24 months

  5. Target vessel revascularization

    Measured: 6, 12, 24 months

  6. Primary patency of treated segment

    Measured: 6, 12, 24 months

  7. Treated limb amputation

    Measured: 30 days, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionSep 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02145065
Sponsor's protocol ID
PAX-0314
Acronym
PAX
Status last verified
Aug 2018
First submitted
20 May 2014
Last updated
7 Aug 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23703720

  • 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.

    PubMed 18272892

  • 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.

    PubMed 18779447

  • 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.

    PubMed 17101615

  • 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.

    PubMed 24456716

  • Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.

    PubMed 42573020

  • 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.

    PubMed 33686879

Questions about this trial

What is this clinical trial studying?

A study testing Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland) and Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland) in people with Peripheral Artery Disease and Femoropopliteal Artery Disease, run by Balton Sp.zo.o. at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Angiographic late lumen loss (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02145065, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.

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