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| Name | Class |
|---|---|
| American Heart of Poland | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plain Balloon Angioplasty | Active Comparator | Plain Balloon Angioplasty |
|
| microcrystalline Paclitaxel Coated Balloon (PAK) | Experimental | plain balloon angioplasty followed by mcPCB dilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland) | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic late lumen loss | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Device related adverse events | 30 days, 6 months | |
| Critical limb ischemia | 30 days, 6 months | |
| Device Success |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lesser-Poland Cardiovascular Center of American Heart of Poland | Chrzanów | 32-500 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23703720 | Background | 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. | |
| 18272892 |
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| Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland) |
| Device |
|
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 |
| Target Lesion Revascularization | 6, 12, 24 months |
| Target vessel revascularization | 6, 12, 24 months |
| Primary patency of treated segment | 6, 12, 24 months |
| Treated limb amputation | 30 days, 6 months |
| 3, 6 and 12 months |
| 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. |
| 18779447 | 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. |
| 17101615 | 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. |
| 24456716 | 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. |
| 33686879 | Derived | 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. |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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