Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-27 @ 4:31 AM
Study NCT ID:
NCT06933992
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-18
First Post:
2025-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Chocolate Balloon Catheter in Peripheral Arterial Disease (CHOCO-PAD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 171}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-07-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2025-04-10', 'studyFirstSubmitQcDate': '2025-04-16', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target lesion patency rate at 12 months post-procedure', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': 'It is defined as the absence of restenosis (based on duplex Doppler ultrasound criteria: diameter stenosis \\>50% and peak systolic velocity ratio \\<2.5) and freedom from target lesion revascularization (TLR).'}], 'secondaryOutcomes': [{'measure': 'Rate of Acute Angiographic Success Defined as Core Lab-Assessed Residual Stenosis ≤30% Without Flow-Limiting Dissection (Grade D or Higher)', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': 'Proportion of participants achieving successful revascularization, defined by two co-primary angiographic criteria: 1) Core laboratory-adjudicated residual stenosis ≤30%, and 2) Absence of flow-limiting dissection (Grade D or higher per NHLBI classification), assessed immediately after device deployment.'}, {'measure': 'Rate of bailout stenting', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': 'The proportion of cases requiring emergency stent placement due to suboptimal Chocolate balloon angioplasty results (e.g., severe dissection, recoil, or residual stenosis).'}, {'measure': 'Number of Participants with Improvement in Rutherford Clinical Category from Baseline', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': 'Proportion of participants achieving ≥1 category reduction in Rutherford Clinical Classification (Scale Range: 0 \\[asymptomatic\\] to 6 \\[major tissue loss\\]) at 12 months post-procedure, as assessed by blinded core lab'}, {'measure': 'Freedom from clinically driven Target Lesion Revascularization (TLR) at 1, 6, and 12 months', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': 'The rate of freedom from repeat revascularization (surgical or endovascular) of the target lesion due to symptoms or worsening blood flow at 1, 6, and 12 months.'}, {'measure': 'Change in Ankle-Brachial Index (ABI) from Baseline', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': 'Mean difference in ABI (normal range: 0.9-1.3) measurements between pre-procedure baseline and 12-month follow-up, assessed by standardized vascular laboratory protocols. Higher values indicate better perfusion.'}, {'measure': 'Change in Toe-Brachial Index (TBI) from Baseline', 'timeFrame': 'From enrollment to the end of treatment at 12 months', 'description': 'Mean difference in TBI (normal \\>0.6) measurements between pre-procedure baseline and 12-month follow-up, assessed by standardized vascular laboratory protocols. Higher values indicate better perfusion.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chocolate Balloon Catheter', 'Percutaneous Transluminal Angioplasty', 'Peripheral Arterial Disease'], 'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'availIpds': [{'url': 'http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml', 'type': 'Study Protocol'}], 'references': [{'pmid': '26490645', 'type': 'RESULT', 'citation': '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': '25775681', 'type': 'RESULT', 'citation': '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': '7895353', 'type': 'RESULT', 'citation': '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': '18206630', 'type': 'RESULT', 'citation': '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': '18254670', 'type': 'RESULT', 'citation': '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': '14656730', 'type': 'RESULT', 'citation': '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': '24402839', 'type': 'RESULT', 'citation': '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': '1617791', 'type': 'RESULT', 'citation': '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': '9740344', 'type': 'RESULT', 'citation': 'Hoffmann R, Mintz GS, Popma JJ, Satler LF, Kent KM, Pichard AD, Leon MB. Treatment of calcified coronary lesions with Palmaz-Schatz stents. An intravascular ultrasound study. Eur Heart J. 1998 Aug;19(8):1224-31. doi: 10.1053/euhj.1998.1028.'}, {'pmid': '20484101', 'type': 'RESULT', 'citation': 'Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR; RESILIENT Investigators. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):267-76. doi: 10.1161/CIRCINTERVENTIONS.109.903468. Epub 2010 May 18.'}, {'pmid': '19859954', 'type': 'RESULT', 'citation': 'Dick P, Wallner H, Sabeti S, Loewe C, Mlekusch W, Lammer J, Koppensteiner R, Minar E, Schillinger M. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv. 2009 Dec 1;74(7):1090-5. doi: 10.1002/ccd.22128.'}, {'pmid': '16672699', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '28251562', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '17140820', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '21963765', 'type': 'RESULT', 'citation': 'Rooke TW, Hirsch AT, Misra S, Sidawy AN, Beckman JA, Findeiss LK, Golzarian J, Gornik HL, Halperin JL, Jaff MR, Moneta GL, Olin JW, Stanley JC, White CJ, White JV, Zierler RE; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology; Society for Vascular Medicine; Society for Vascular Surgery. 2011 ACCF/AHA Focused Update of the Guideline for the Management of Patients With Peripheral Artery Disease (updating the 2005 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2011 Nov 1;58(19):2020-45. doi: 10.1016/j.jacc.2011.08.023. Epub 2011 Oct 6. No abstract available.'}, {'pmid': '21873417', 'type': 'RESULT', 'citation': 'European Stroke Organisation; Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clement D, Collet JP, Cremonesi A, De Carlo M, Erbel R, Fowkes FG, Heras M, Kownator S, Minar E, Ostergren J, Poldermans D, Riambau V, Roffi M, Rother J, Sievert H, van Sambeek M, Zeller T; ESC Committee for Practice Guidelines. ESC Guidelines on the diagnosis and treatment of peripheral artery diseases: Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011 Nov;32(22):2851-906. doi: 10.1093/eurheartj/ehr211. Epub 2011 Aug 26. No abstract available.'}, {'pmid': '28128018', 'type': 'RESULT', 'citation': 'Lawall H, Huppert P, Espinola-Klein C, Zemmrich CS, Ruemenapf G. German guideline on the diagnosis and treatment of peripheral artery disease - a comprehensive update 2016. Vasa. 2017 Mar;46(2):79-86. doi: 10.1024/0301-1526/a000603. Epub 2017 Jan 27.'}, {'pmid': '17848483', 'type': 'RESULT', 'citation': 'Zeller T. Current state of endovascular treatment of femoro-popliteal artery disease. Vasc Med. 2007 Aug;12(3):223-34. doi: 10.1177/1358863X07079823.'}, {'pmid': '2673321', 'type': 'RESULT', 'citation': 'McDaniel MD, Cronenwett JL. Basic data related to the natural history of intermittent claudication. Ann Vasc Surg. 1989 Jul;3(3):273-7. doi: 10.1016/S0890-5096(07)60040-5. No abstract available.'}, {'pmid': '2647761', 'type': 'RESULT', 'citation': 'Dormandy J, Mahir M, Ascady G, Balsano F, De Leeuw P, Blombery P, Bousser MG, Clement D, Coffman J, Deutshinoff A, et al. Fate of the patient with chronic leg ischaemia. A review article. J Cardiovasc Surg (Torino). 1989 Jan-Feb;30(1):50-7.'}, {'pmid': '23915883', 'type': 'RESULT', 'citation': 'Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.'}, {'pmid': '25432124', 'type': 'RESULT', 'citation': 'Sampson UK, Fowkes FG, McDermott MM, Criqui MH, Aboyans V, Norman PE, Forouzanfar MH, Naghavi M, Song Y, Harrell FE Jr, Denenberg JO, Mensah GA, Ezzati M, Murray C. Global and regional burden of death and disability from peripheral artery disease: 21 world regions, 1990 to 2010. Glob Heart. 2014 Mar;9(1):145-158.e21. doi: 10.1016/j.gheart.2013.12.008.'}, {'pmid': '14709362', 'type': 'RESULT', 'citation': 'Diehm C, Schuster A, Allenberg JR, Darius H, Haberl R, Lange S, Pittrow D, von Stritzky B, Tepohl G, Trampisch HJ. High prevalence of peripheral arterial disease and co-morbidity in 6880 primary care patients: cross-sectional study. Atherosclerosis. 2004 Jan;172(1):95-105. doi: 10.1016/s0021-9150(03)00204-1.'}, {'pmid': '10073955', 'type': 'RESULT', 'citation': 'Newman AB, Shemanski L, Manolio TA, Cushman M, Mittelmark M, Polak JF, Powe NR, Siscovick D. Ankle-arm index as a predictor of cardiovascular disease and mortality in the Cardiovascular Health Study. The Cardiovascular Health Study Group. Arterioscler Thromb Vasc Biol. 1999 Mar;19(3):538-45. doi: 10.1161/01.atv.19.3.538.'}, {'pmid': '41083315', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/', 'label': 'Description the protocol of the study'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe main question it aims to answer is:\n\nDoes 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be selected from patients diagnosed with symptomatic peripheral artery disease (Rutherford class 2-5) who are undergoing percutaneous transluminal angioplasty (PTA) with the Chocolate balloon catheter as part of standard care. The ages of participants range from 18 to 80 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant or legal guardian provides written informed consent.\n* Age ≥18 and ≤80 years, regardless of gender.\n* De novo target lesion located in the native superficial femoral, popliteal, or infrapopliteal artery.\n* Life expectancy \\>1 year as assessed by the investigator.\n* Candidate suitable for endovascular angiography and intervention per investigator judgment.\n* Willingness to undergo Chocolate Balloon Catheter PTA.\n\nExclusion Criteria:\n\n* Active systemic infection or uncontrolled coagulation disorder within 14 days prior to procedure.\n* Planned major amputation of the target limb (at or above the ankle).\n* Renal insufficiency (MDRD eGFR ≤30 mL/min/1.73 m²) or serum creatinine ≥2.5 mg/dL within 30 days, or dialysis dependence.\n* Contraindication to antiplatelet therapy (aspirin/clopidogrel), low-molecular-weight heparin, vasodilators, or contrast agents.\n* Uncontrolled systemic comorbidities (e.g., severe cardiac/pulmonary/hepatic dysfunction, advanced malignancy, uncorrected coagulopathy).\n* History of cerebral hemorrhage, symptomatic stroke, myocardial infarction, or gastrointestinal bleeding within 6 months.\n* Pregnancy, lactation, or planned pregnancy (men or women).\n* Participation in another interventional clinical trial with unmet primary endpoint.\n* Investigator-determined medical, social, or psychological contraindications.\n* Life expectancy \\<1 year.'}, 'identificationModule': {'nctId': 'NCT06933992', 'acronym': 'CHOCO-PAD', 'briefTitle': 'Safety and Efficacy of Chocolate Balloon Catheter in Peripheral Arterial Disease (CHOCO-PAD)', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Hangzhou"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NV-001-HZFH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chocolate PTA for PAD', 'description': '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.', 'interventionNames': ['Device: Chocolate PTA Balloon Catheter']}], 'interventions': [{'name': 'Chocolate PTA Balloon Catheter', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Chocolate PTA for PAD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'country': 'China', 'facility': "Hangzhou First People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Meng Xiaohu, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First People's Hospital of Hangzhou"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to privacy and confidentiality concerns, individual participant data (IPD) will not be shared. The data contains sensitive health information that is protected by regulations, and sharing it may compromise participant confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}