Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-04-08 @ 2:41 PM
Study NCT ID:
NCT07010094
Status:
RECRUITING
Last Update Posted:
2025-07-25
First Post:
2025-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BM Shockwave Devices Clinical Study in Coronary Calcified Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2025-05-28', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure success rate', 'timeFrame': 'Endpoints will be measured through hospital discharge (expected to be within 7 days)', 'description': 'Definition: Residual stenosis ≤30% after PCI, and no major adverse cardiac events (MACE) events occurring during hospitalization. MACE is defined as cardiac death, myocardial infarction, and target vessel revascularization events.'}], 'secondaryOutcomes': [{'measure': 'Angiography success rate', 'timeFrame': '0 day', 'description': 'Definition: After successful stent placement in the target lesion, residual stenosis ≤ 30%, and no serious angiography complications occur.\n\nSerious angiography complications: refer to the occurrence of D-F type dissection, vascular perforation, acute vascular occlusion, persistent slow blood flow, or no reperfusion during the procedure.'}, {'measure': 'Device success rate', 'timeFrame': '0 day', 'description': 'The study device successfully passes through the target lesion, and no serious angiographic complications occur immediately after shockwave pretreatment.'}, {'measure': 'Residual stenosis', 'timeFrame': '0 day', 'description': 'Degree of residual stenosis immediately after shockwave pretreatment of the target lesion.'}, {'measure': 'MACE rate', 'timeFrame': '30 days', 'description': 'MACE is defined as cardiac death, myocardial infarction, and target vessel revascularization events.'}, {'measure': 'Target lesion failure', 'timeFrame': '30 days', 'description': 'Target lesion failure (TLF) definition: Includes cardiac death, myocardial infarction caused by target vessel (ST-segment elevation or non-ST-segment elevation myocardial infarction), and target lesion revascularization.'}, {'measure': 'Device defects', 'timeFrame': '0 day', 'description': 'Incidence of device defects'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary artery disease', 'shockwave therapy', 'Coronary calcified lesions'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This clinical trial is a prospective, multicenter, single-arm, target-value study to verify the safety and efficacy of BM coronary shockwave devices for the treatment of coronary calcification lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* General inclusion criteria:\n\n 1. Age 18-85 years, male or female;\n 2. Patients with evidence of asymptomatic ischemia, stable or unstable angina, or old myocardial infarction;\n 3. Patient is able and willing to comply with all assessments in the study.\n\nAngiography inclusion criteria:\n\n1. The target lesion is a de novo, in-situ coronary artery lesion;\n2. The target lesion length is ≤40 mm, and the target lesion reference vessel diameter is 2.0-4.0 mm (visual estimation);\n3. The target lesion diameter stenosis is visually estimated to be ≥70%, or \\<70% but ≥50% with evidence of ischemia;\n4. Clear high-density calcification shadows are visible both during cardiac contraction and at rest;\n5. Target vessel TIMI flow grade 3 prior to use of the investigational device (pre-dilatation is permitted);\n6. The target lesion is the only calcified lesion to be treated with shock wave therapy in this session; if non-target lesions are present, they must be successfully treated prior to the target lesion;\n7. Patients suitable for treatment with metal stent implantation.\n\nExclusion Criteria:\n\n* General exclusion criteria:\n\n 1. ST-segment elevation myocardial infarction within 3 days prior to the procedure;\n 2. Use of rotational atherectomy or special balloons (chocolate balloon, scoring balloon, cutting balloon, etc.) for lesion pretreatment;\n 3. New York Heart Association (NYHA) functional class III or IV;\n 4. Target lesion expected to require full biodegradable scaffold implantation, drug-eluting balloon dilation, or percutaneous transluminal coronary angioplasty (PTCA) treatment;\n 5. Uncontrolled severe hypertension (persistent: systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg);\n 6. Severe liver or kidney dysfunction, with transaminase levels exceeding three times the upper limit of normal, serum creatinine \\>2.5 mg/dL (221 μmol/L), or chronic kidney failure requiring long-term dialysis;\n 7. Platelet count \\<60 × 10⁹/L;\n 8. Stroke within the past 6 months prior to enrollment, excluding transient ischemic attack (TIA) and lacunar infarction;\n 9. Active peptic ulcer or history of upper gastrointestinal bleeding within the past 6 months prior to enrollment;\n 10. Known allergy to heparin, contrast agents, aspirin, clopidogrel, or anesthetics;\n 11. Patients with a life expectancy of less than 12 months due to severe medical conditions;\n 12. Patients who have participated in other drug or device clinical trials and failed to meet the primary endpoint;\n 13. Pregnant or breastfeeding women;\n 14. Patients deemed by the investigator to have poor compliance and unable to complete the study according to the protocol.\n\nContrast exclusion criteria:\n\n1. The target lesion and non-target lesion are in the same vascular branch;\n2. The target lesion is at the origin (LAD, LCX, or RCA, within 5 mm of the origin) or an unprotected left main lesion;\n3. A stent has been implanted within 10 mm of the proximal or distal end of the target lesion;\n4. The target lesion has an unprotected branch vessel with a diameter of 2.5 mm or greater;\n5. The target lesion is located distal to the saphenous vein or LIMA (left internal mammary artery)/RIMA (right internal mammary artery) bypass graft;\n6. An aneurysm is present within 10 mm of the target lesion;\n7. Contrast imaging confirms the presence of an NHLBI classification D-F type arterial dissection at the target lesion prior to the use of the investigational device;\n8. The target lesion has definite thrombus formation;\n9. The investigator determines that the target lesion is not suitable for vascular dilation in the patient.'}, 'identificationModule': {'nctId': 'NCT07010094', 'briefTitle': 'BM Shockwave Devices Clinical Study in Coronary Calcified Lesions', 'organization': {'class': 'INDUSTRY', 'fullName': 'BrosMed Medical Co., Ltd'}, 'officialTitle': 'A Prospective, Multicenter, Single-arm, Target-Value Clinical Trial to Evaluate the Safety and Efficacy of BM Shockwave Devices to Treat Coronary Calcified Lesions', 'orgStudyIdInfo': {'id': 'D24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test group', 'interventionNames': ['Device: BM shockwave devices']}], 'interventions': [{'name': 'BM shockwave devices', 'type': 'DEVICE', 'description': 'Use the BM shockwave devices for pre-treatment of coronary calcification lesions.', 'armGroupLabels': ['Test group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '361000', 'city': 'Fujian', 'state': 'Xiamen', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wang Yan, Ph.', 'role': 'CONTACT'}], 'facility': 'Xiamen University Affiliated Cardiovascular Hospital', 'geoPoint': {'lat': 28.92651, 'lon': 106.12972}}], 'centralContacts': [{'name': 'Wang Yan, Professor', 'role': 'CONTACT', 'email': 'wy@medmail.com.cn', 'phone': '0592-968120'}, {'name': 'Wang Yan', 'role': 'CONTACT', 'email': 'wy@medmail.com.cn', 'phone': '0592-968120'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BrosMed Medical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}