Safety and Efficacy of Chocolate Balloon Catheter in Peripheral Arterial Disease (CHOCO-PAD)

Официальное название

Evaluation of the Safety and Efficacy of the Chocolate Balloon Catheter in Percutaneous Transluminal Angioplasty (PTA) for Peripheral Arterial Disease (PAD): A Prospective, Multicenter, Single-Arm Observational Trial

Обзор

This study aims to learn about the long-term safety and effectiveness of the Chocolate Balloon Catheter in patients with blocked leg arteries (peripheral artery disease, or PAD). The Chocolate Balloon is a special type of balloon used during minimally invasive procedures to open narrowed arteries while potentially causing less damage to the blood vessel. The main question it aims to answer is: Does the Chocolate Balloon keep the treated artery open after 12 months without needing repeat procedures? Patients with PAD who are already scheduled to undergo an artery-opening procedure (angioplasty) with the Chocolate Balloon as part of their standard care will answer the question about the safety and effectiveness of the Chocolate Balloon Catheter

Вмешательства

• Устройство Chocolate PTA Balloon Catheter
  The Chocolate PTA balloon catheter is a nitinol-constrained percutaneous transluminal angioplasty balloon designed to minimize vessel trauma during treatment of peripheral arterial lesions. The device is used according to its standard indications and instructions for use in patients with symptomatic peripheral artery disease.

Первичные конечные точки

• Target lesion patency rate at 12 months post-procedure [Срок оценки: From enrollment to the end of treatment at 12 months]

Вторичные конечные точки (6)

• Rate of Acute Angiographic Success Defined as Core Lab-Assessed Residual Stenosis ≤30% Without Flow-Limiting Dissection (Grade D or Higher) [Срок оценки: From enrollment to the end of treatment at 12 months]
• Rate of bailout stenting [Срок оценки: From enrollment to the end of treatment at 12 months]
• Number of Participants with Improvement in Rutherford Clinical Category from Baseline [Срок оценки: From enrollment to the end of treatment at 12 months]
• Freedom from clinically driven Target Lesion Revascularization (TLR) at 1, 6, and 12 months [Срок оценки: From enrollment to the end of treatment at 12 months]
• Change in Ankle-Brachial Index (ABI) from Baseline [Срок оценки: From enrollment to the end of treatment at 12 months]
• Change in Toe-Brachial Index (TBI) from Baseline [Срок оценки: From enrollment to the end of treatment at 12 months]

Критерии участия

Критерии включения

• Participant or legal guardian provides written informed consent.
• Age ≥18 and ≤80 years, regardless of gender.
• De novo target lesion located in the native superficial femoral, popliteal, or infrapopliteal artery.
• Life expectancy >1 year as assessed by the investigator.
• Candidate suitable for endovascular angiography and intervention per investigator judgment.
• Willingness to undergo Chocolate Balloon Catheter PTA.

Критерии исключения

• Active systemic infection or uncontrolled coagulation disorder within 14 days prior to procedure.
• Planned major amputation of the target limb (at or above the ankle).
• Renal insufficiency (MDRD eGFR ≤30 mL/min/1.73 m²) or serum creatinine ≥2.5 mg/dL within 30 days, or dialysis dependence.
• Contraindication to antiplatelet therapy (aspirin/clopidogrel), low-molecular-weight heparin, vasodilators, or contrast agents.
• Uncontrolled systemic comorbidities (e.g., severe cardiac/pulmonary/hepatic dysfunction, advanced malignancy, uncorrected coagulopathy).
• History of cerebral hemorrhage, symptomatic stroke, myocardial infarction, or gastrointestinal bleeding within 6 months.
• Pregnancy, lactation, or planned pregnancy (men or women).
• Participation in another interventional clinical trial with unmet primary endpoint.
• Investigator-determined medical, social, or psychological contraindications.
• Life expectancy <1 year.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Hangzhou First People's Hospital — Ханчжоу

Публикации

• Babaev A, Zavlunova S, Attubato MJ, Martinsen BJ, Mintz GS, Maehara A. Orbital Atherectomy Plaque Modification Assessment of the Femoropopliteal Artery Via Intravascular Ultrasound (TRUTH Study). Vasc Endovascular Surg. 2015 Oct;49(7):188-94. doi: 10.1177/1538574415607361. Epub 2015 Oct 20. PMID 26490645
• Lee MS, Canan T, Rha SW, Mustapha J, Adams GL. Pooled analysis of the CONFIRM registries: impact of gender on procedure and angiographic outcomes in patients undergoing orbital atherectomy for peripheral artery disease. J Endovasc Ther. 2015 Feb;22(1):57-62. doi: 10.1177/1526602814564367. PMID 25775681
• Mintz GS, Popma JJ, Pichard AD, Kent KM, Satler LF, Chuang YC, Ditrano CJ, Leon MB. Patterns of calcification in coronary artery disease. A statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation. 1995 Apr 1;91(7):1959-65. doi: 10.1161/01.cir.91.7.1959. PMID 7895353
• Kawaguchi R, Tsurugaya H, Hoshizaki H, Toyama T, Oshima S, Taniguchi K. Impact of lesion calcification on clinical and angiographic outcome after sirolimus-eluting stent implantation in real-world patients. Cardiovasc Revasc Med. 2008 Jan-Mar;9(1):2-8. doi: 10.1016/j.carrev.2007.07.004. PMID 18206630
• Kashyap VS, Pavkov ML, Bishop PD, Nassoiy SP, Eagleton MJ, Clair DG, Ouriel K. Angiography underestimates peripheral atherosclerosis: lumenography revisited. J Endovasc Ther. 2008 Feb;15(1):117-25. doi: 10.1583/07-2249R.1. PMID 18254670
• Allison MA, Criqui MH, Wright CM. Patterns and risk factors for systemic calcified atherosclerosis. Arterioscler Thromb Vasc Biol. 2004 Feb;24(2):331-6. doi: 10.1161/01.ATV.0000110786.02097.0c. Epub 2003 Dec 4. PMID 14656730
• Rocha-Singh KJ, Zeller T, Jaff MR. Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv. 2014 May 1;83(6):E212-20. doi: 10.1002/ccd.25387. Epub 2014 Feb 10. PMID 24402839
• Fitzgerald PJ, Ports TA, Yock PG. Contribution of localized calcium deposits to dissection after angioplasty. An observational study using intravascular ultrasound. Circulation. 1992 Jul;86(1):64-70. doi: 10.1161/01.cir.86.1.64. PMID 1617791

Идентификаторы

NCT: NCT06933992 · NV-001-HZFH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗