A prospective, multi‐center study of the chocolate balloon in femoropopliteal peripheral artery disease: The <scp>C</scp>hocolate <scp>BAR</scp> registry

Mustapha, Jihad; Lansky, Alexandra J.; Shishehbor, Mehdi H.; Mcclure, John Miles; Johnson, Sarah A.; Davis, Thomas P.; Makam, Prakash; Crowder, William; Konstantino, Eitan; Attaran, Robert R.

doi:10.1002/ccd.27565

Cited by 33 publications

(22 citation statements)

References 22 publications

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“…A more contemporary study involving the use of the Chocolate balloon in femoropopliteal disease cites low rates of dissection (22.5%) and bailout stenting (1.6%), but the lesion lengths were only 83.5 mm on average, with fewer CTOs (23.1%). 38 Not surprisingly, dissection was associated with a heightened risk for provisional stenting. Historically, the rate of flow-limiting dissection during balloon dilation of peripheral arteries has been high.…”

Section: Discussionmentioning

confidence: 99%

Acute Outcomes With a Novel Plaque Modification System in Real-World Femoropopliteal Lesions

Zeller

Lopez

Pigott³

2019

J Endovasc Ther

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Purpose: To report outcomes of a multicenter feasibility study using the FLEX Vessel Prep (VP) System, a novel technology that facilitates plaque incision and lumen gain in stenosed or occluded femoropopliteal arteries prior to balloon angioplasty. Materials and Methods: Two hundred fifty-five patients (mean age 71.8±9.1 years) were treated with the FLEX VP System at 38 centers between December 2015 and November 2017. Average lesion length was 133±88 mm. Average baseline stenosis was 92%±11%; 112 (44.3%) of 253 patients presented with a chronic total occlusion. Conventional or drug-coated balloon (DCB) angioplasty was performed in all patients after vessel preparation. Vessel measurements were derived from angiograms acquired at baseline, after FLEX passage, and after subsequent ancillary procedures. Logistic regression analyses were performed to identify baseline or procedure variables that predicted the need for provisional stenting. Results: Average percent reduction in vessel stenosis following treatment with the FLEX VP System was 27%±17%. No flow-limiting dissection, vessel perforation, or embolization was observed; 15 (5.9%) patients had minor (type A or B) dissections. Provisional stenting was performed in 49 (19.2%) patients. Average stenosis following angioplasty ± stenting was 9.1%±7.4%; 9 (3.6%) patients had significant residual stenosis ≥30%. Logistic regression analyses found that patients with dissections, longer lesions, and those receiving conventional balloon dilation alone were most likely to undergo stenting. Conclusion: In a real-world patient population with long, complex femoropopliteal lesions, use of the FLEX VP System as vessel preparation for angioplasty improved acute outcomes compared to historical controls. The rate of provisional stenting was low, and no serious vessel complications were observed.

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Section: Discussionmentioning

confidence: 99%

Acute Outcomes With a Novel Plaque Modification System in Real-World Femoropopliteal Lesions

Zeller

Lopez

Pigott³

2019

J Endovasc Ther

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“…In the Chocolate Balloon Angioplasty Registry (BAR) (NCT01589042), procedural success was reported for 85.1% of cases, and freedom from stenting occurred in 93.1%. Bailout stenting by independent adjudication occurred in 1.6% of cases, and there were no flow‐limiting dissections.…”

Section: Discussionmentioning

confidence: 99%

“…A combination of either treatment strategy has been recently become available which is a paclitaxel‐covered balloon and constrained by a nitinol structure that creates pillows and grooves in the balloon. It also provides fast deflation and uniform rewrap (chocolate drug‐eluting PTA balloon catheter (C‐DEB PTA) . In this case report, we describe—to the best of our knowledge—the first successful percutaneous transluminal angioplasty with a nitinol‐structured (chocolate‐like) drug‐coated (paclitaxel) balloon technology (C‐DEB PTA) in a patient with TA.…”

Section: Introductionmentioning

confidence: 97%

Recanalization of bilateral axillaris/brachialis artery occlusion in a patient with Takayashu arteritis: First case report on using a novel drug‐coated nitinol “chocolate” balloon catheter

Leigh

Kor

Czantrak

et al. 2018

Clinical Case Reports

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“…It also creates "pillows" and "grooves" that provide stress relief points that allow for plaque modification, limit dissection and at the same time increase the contact surface area to 120%. The Chocolate PTA balloon catheter demonstrated excellent procedural outcomes with low dissection rates and bailout stent use in a prospective registry (Mustapha et al, 2018), and the antiproliferative drug-coated version (Chocolate Touch) had almost 90% 12 month patency in the small single arm ENDURE trial of complex lesions (Shishehbor et al, 2016). The Vascu-Trak device (BARD, NJ, USA) is a similar scoring balloon, characterised by two longitudinal wires along the length of the balloon causing partial constraint, which has been evaluated in a safety and efficacy trial with good success (Baumhäkel et al, 2018).…”

Section: Other Balloon-based Devicesmentioning

confidence: 92%

An update on vessel preparation in lower limb arterial intervention

et al. 2020

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Background Plain balloon angioplasty has traditionally been used to treat lower limb arterial disease but can be limited by significant residual stenosis, vessel recoil, dissection, and by late restenosis. Appropriate vessel preparation may significantly improve short and long-term outcomes. We aim to give an overview of some of the devices currently available, or under investigation, for vessel preparation in the lower limb. Main text Vessel preparation devices include those that remove plaque (atherectomy devices) and those that modify plaque. The four groups of plaque removing atherectomy devices are defined by their plaque removal method: Directional, rotational orbital and excimer laser are categories of devices investigated for plaque modification. Intravascular lithotripsy devices generate sonic pulsatile pressure waves that pass into the vessel wall cracking calcified plaques whilst sparing soft tissue. This enables dilatation of calcified lesions at low pressure by conventional balloons and enables full stent expansion. Other balloon based vessel preparation devices were designed to modify plaque and produce more controlled, lower pressure luminal expansion without major dissections and potentially with less recoil than conventional angioplasty balloons. Scoring balloons have a helical nitinol element attached to the balloon that scores plaque facilitating uniform luminal enlargement. Further specialty balloons have been developed in recent years, including the Chocolate, Phoenix and Serranator balloons. Finally, the temporary Spur self-expanding retrievable nitinol stent has a series of radially aligned spurs that are driven into the vessel wall by post-dilatation, potentially improving drug delivery. Conclusion Lesion specific vessel preparation aims to improve both short and long term outcomes through improved penetration of anti-proliferative drug, maximising luminal gain, reducing the need for stent placement and minimising intimal injury. Some forms of vessel preparation appear to improve short term outcomes; long-term outcomes remain uncertain. An overview of some of the multiple devices available for vessel preparation is presented.

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A prospective, multi‐center study of the chocolate balloon in femoropopliteal peripheral artery disease: The Chocolate BAR registry

Cited by 33 publications

References 22 publications

Acute Outcomes With a Novel Plaque Modification System in Real-World Femoropopliteal Lesions

Acute Outcomes With a Novel Plaque Modification System in Real-World Femoropopliteal Lesions

Recanalization of bilateral axillaris/brachialis artery occlusion in a patient with Takayashu arteritis: First case report on using a novel drug‐coated nitinol “chocolate” balloon catheter

An update on vessel preparation in lower limb arterial intervention

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