Randomized Controlled Trial of Acotec Drug-Eluting Balloon Versus Plain Balloon for Below-the-Knee Angioplasty

Liïstro, Francesco; Angioli, Paolo; Ventoruzzo, Giorgio; Ducci, Kenneth; Reccia, Matteo Rocco; Ricci, Lucia; Falsini, Giovanni; Scatena, Alessia; Pieroni, Maurizio; Bolognese, Leonardo

doi:10.1016/j.jcin.2020.06.045

Cited by 43 publications

(29 citation statements)

References 16 publications

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“…Several smaller studies from centers with well-defined wound care programs reported a significant benefit for DCB treatment BTK. [10][11][12] In contrast, other randomized multicenter studies did not show an advantage in terms of restenosis or safety parameters such as amputation. 13,14 The reasons for the contradictory results of DCB in the BTK indication are not yet fully understood.…”

Section: Introductionmentioning

confidence: 82%

Preclinical Evaluation of the Temporary Drug-Coated Spur Stent System in Porcine Peripheral Arteries

Brunacci¹,

Schurmann-Kaufeld²,

Haase

et al. 2021

J Endovasc Ther

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Background: Drug penetration into the deeper arterial wall of heavily calcified lesions is one of the limitations of drug-coated balloons and drug-eluting stents in vascular interventions. The Temporary Spur Stent (TSS) system is characterized by a self-expanding nitinol stent that is uniformly covered in radialspikes, which, when coated, should allow a deeper penetration and longer retention of the drug into the diseased artery walls by penetrating through the calcified plaques. Materials and Methods and Results: Uncoated TSS and paclitaxel (PTX)-coated TSS systems have been deployed in porcine peripheral arteries. Four weeks after the deployment of uncoated TSS systems, no adverse vascular remodeling or neointimal formation in the treated vessel segments were noticed. PTX-coated TSS systems transferred 9%±7% of the drug that was on the device to the targeted vessel area (196±163 ng PTX/mg arterial tissue) and the addition of the fluorescent dye Nile red to the coating showed that the spikes promote the transfer of the coating to the deeper layers of the vessel wall. The PTX-coated TSS systems showed a significant reduction in neointimal proliferation compared to the uncoated TSS systems: quantitative angiography showed a vessel diameter stenosis of 37.2%±11.0% and 16.4%±8.8% 4 weeks after the treatment with uncoated and PTX-coated TSS systems, respectively. Conclusion: The treatment with the TSS system was well tolerated and the spikesfacilitate the transfer of the coating into deeper layers of the vessel wall. Moreover, the PTX-coated TSS systems effectively inhibit neointimal proliferation.

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Section: Introductionmentioning

confidence: 82%

Preclinical Evaluation of the Temporary Drug-Coated Spur Stent System in Porcine Peripheral Arteries

Brunacci¹,

Schurmann-Kaufeld²,

Haase

et al. 2021

J Endovasc Ther

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show abstract

“…Additional published clinical trials are tabulated (Tables 3 (Ref. [52][53][54][55][56][57][58][59][60][61][62][63]),4 (Ref. [52][53][54][55][56][57][58][59][60][61][62][63]),5 (Ref.…”

Section: Summary Of Pcb Clinical Trialsmentioning

confidence: 99%

“…[52][53][54][55][56][57][58][59][60][61][62][63]),4 (Ref. [52][53][54][55][56][57][58][59][60][61][62][63]),5 (Ref. [52][53][54][55][56][57][58][59][60][61][62][63]),6 (Ref.…”

Section: Summary Of Pcb Clinical Trialsunclassified

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Progress on developing an effective below-the-knee drug-coated balloon

Khoury¹,

Brodmann²,

Schneider³

2021

Reviews in Cardiovascular Medicine

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Infrapopliteal atherosclerotic disease continues to present the greatest conundrum for effective endovascular therapies. To date, conventional angioplasty has been fraught with early restenosis and recoil in these complex, long, calcified, and occlusive lesions. The success of metallic drug-eluting stents in coronary arteries has not carried over to below-the-knee arteries. Initial promise in paclitaxel-coated balloons has not been demonstrated in large randomized clinical trials. Furthermore, the potential association between paclitaxel and mortality continues to generate tremendous controversy. The goal of this review article is to discuss the evolution and challenges of drugcoated balloon (DCB) science, present the clinical results of currently available tibial DCBs, and introduce new horizons in DCB technology.

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“…Wirksamkeit und Sicherheit Paclitaxel-beschichteter Ballons (PCB) werden noch kontrovers diskutiert. Lediglich in der monozentrischen, randomisierten ACOART-BTK Studie [3] waren ein Jahr Gefäßmedizin Scan 2021; 8: Seiten: 240 -242, DOI: 10.1055/a-1666-5412 | © 2021. Thieme.…”

Section: Kommentarunclassified

Sirolimus-freisetzende Ballonangioplastie bei komplexen Tibialisverschlüssen

2021

Gefäßmedizin Scan - Zeitschrift für Angiologie, Gefäßchirurgie,

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Randomized Controlled Trial of Acotec Drug-Eluting Balloon Versus Plain Balloon for Below-the-Knee Angioplasty

Cited by 43 publications

References 16 publications

Preclinical Evaluation of the Temporary Drug-Coated Spur Stent System in Porcine Peripheral Arteries

Preclinical Evaluation of the Temporary Drug-Coated Spur Stent System in Porcine Peripheral Arteries

Progress on developing an effective below-the-knee drug-coated balloon

Sirolimus-freisetzende Ballonangioplastie bei komplexen Tibialisverschlüssen

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