Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2026-01-25 @ 8:41 AM
Study NCT ID:
NCT06669195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-01
First Post:
2024-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D002114', 'term': 'Calcinosis'}], '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'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-03-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the thickness of neointima', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intravascular lithotripsy', 'stent under-expansion', 'calcified coronary lesions'], 'conditions': ['Coronary Artery Disease', 'Calcification']}, 'descriptionModule': {'briefSummary': 'Percutaneous coronary intervention (PCI) is the standard treatment for patients with coronary artery disease who have an indication for surgery. Coronary artery calcification not only makes stent delivery and expansion more difficult during PCI, but also increases the risk of vessel perforation. In addition, calcified plaque can lead to incomplete stent expansion, which increases the risk of in-stent restenosis and thrombosis. Although the technology and techniques of interventional devices continue to improve, heavily calcified lesions remain an important risk factor for PCI failure.\n\nThis study is a prospective, multicenter, randomized study. It is planned to select 40 cases of subjects with calcified plaque can lead to incomplete stent expansion who meet the inclusion/exclusion criteria. They are randomly dividing them into Intravascular lithotripsy treatment group and high-pressure balloon treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, and 12 months after operation. Follow-up with angiography and OCT are conducted at 12 months. The primary endpoint was thickness of neointima at 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radiography inclusion criteria\n\n 1. the angiography identified a severely calcified lesion with acute stent under-expansion, i.e., residual stenosis \\>20% after stenting and 16-atm dilatation with a post-dilatation balloon;\n 2. target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);\n 3. target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤30 mm (visual assessment);\n\nGeneral inclusion criteria\n\n1. subjects at the age between ≥18 and ≤80 years old;\n2. patients with symptoms or evidence of myocardial ischaemia;\n3. subjects are willing to participate in the study, sign informed consent form, and accept clinical and angiography follow-up after PCI.\n\nExclusion Criteria:\n\n* Radiography exclusion criteria\n\n 1. in-stent lesions;\n 2. For the left main disease and bifurcation lesion (branch vessel diameter shall be ≥ 2.5mm);\n 3. Target lesions were total occlusive lesions (acute or chronic), long lesions (\\>30 mm), lesion vessel reference diameters \\>4.0 mm, and lesion angiomatous dilatation;\n\nGeneral inclusion criteria\n\n1. Patients with severe congestive heart failure (NYHA Level IV severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 35%;\n2. Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;\n3. Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;\n4. Patients with severe renal failure(eGFR\\<30ml/minute) or such medical history, failure to comply with angiography conditions;\n5. Subjects who are intolerance or allergic to heparin, contrast agent, Biolimus, polyethylene oxide and polylactic acid - glycolic acid polymer;\n6. Patients who plans to accept selective operation within 1 year;\n7. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;\n8. Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.'}, 'identificationModule': {'nctId': 'NCT06669195', 'briefTitle': 'Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions', 'organization': {'class': 'OTHER', 'fullName': "Xuzhou Third People's Hospital"}, 'officialTitle': 'Feasibility and Safety of Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions', 'orgStudyIdInfo': {'id': '2024-02-007-H01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravascular lithotripsy group', 'interventionNames': ['Device: Intravascular lithotripsy group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high-pressure balloon group', 'interventionNames': ['Device: high-pressure balloon group']}], 'interventions': [{'name': 'Intravascular lithotripsy group', 'type': 'DEVICE', 'description': '20 subjects with stent under-expansion in calcified coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of Intravascular lithotripsy group.', 'armGroupLabels': ['Intravascular lithotripsy group']}, {'name': 'high-pressure balloon group', 'type': 'DEVICE', 'description': '20 subjects with stent under-expansion in calcified coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of high-pressure balloon group.', 'armGroupLabels': ['high-pressure balloon group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'yaojun zhang, Ph.D.', 'role': 'CONTACT', 'email': 'mts0207@163.com', 'phone': '0516-85786383'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Xuzhou Third People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}