Safety and Efficacy of Chocolate Balloon Catheter in Peripheral Arterial Disease (CHOCO-PAD)
NCT ID: NCT06933992
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
171 participants
OBSERVATIONAL
2025-07-20
2027-12-20
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chocolate PTA for PAD
This cohort comprises patients with symptomatic peripheral artery disease (Rutherford class 2-5) undergoing percutaneous transluminal angioplasty (PTA) using the Chocolate balloon catheter as part of routine care. Participants will be prospectively followed for 12 months to assess target lesion patency, revascularization rates, and clinical outcomes. Inclusion criteria: age ≥18 years, de novo/restenotic lesions (≤150 mm) in native lower limb arteries, and reference vessel diameter 4-6 mm.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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First People's Hospital of Hangzhou
OTHER
Responsible Party
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Principal Investigators
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Meng Xiaohu, MS
Role: PRINCIPAL_INVESTIGATOR
First People's Hospital of Hangzhou
Locations
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Hangzhou First People's Hospital
Hangzhou, , China
Countries
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References
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Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006 May 4;354(18):1879-88. doi: 10.1056/NEJMoa051303.
Yokoi Y. How should recent endovascular trials for femoropopliteal artery disease be interpreted? Cardiovasc Interv Ther. 2017 Apr;32(2):106-113. doi: 10.1007/s12928-017-0463-z. Epub 2017 Mar 1.
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
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Ye ZQ, Liu H, Fang X, Meng XH. Safety and effectiveness of the Chocolate balloon catheter in the treatment of peripheral artery disease with percutaneous transluminal angioplasty: a multicentre, prospective, observational study protocol. BMJ Open. 2025 Oct 13;15(10):e103906. doi: 10.1136/bmjopen-2025-103906.
Study Documents
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Document Type: Study Protocol
View DocumentRelated Links
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Description the protocol of the study
Other Identifiers
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NV-001-HZFH
Identifier Type: -
Identifier Source: org_study_id
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