Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:18 AM
Study NCT ID:
NCT07336433
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-13
First Post:
2025-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SMART-IC-Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-12', 'studyFirstSubmitDate': '2025-12-18', 'studyFirstSubmitQcDate': '2026-01-12', 'lastUpdatePostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Success rate of the renal interventional therapy procedure', 'timeFrame': 'Immediately after the procedure and at 7 days post-procedure (or prior to discharge, whichever occurs first', 'description': 'The renal denervation catheter can be engaged to the correct position in renal artery, successfully performed renal nerve ablation procedure and has no related complications such as renal arterial perforation;'}, {'measure': 'Success rate of clinical treatment', 'timeFrame': 'Immediately after the procedure and at 7 days post-procedure (or prior to discharge, whichever occurs first', 'description': 'Based on succeed performance of renal interventional therapy procedure , there are no the procedure-related SAE, such as acute infection and renal dysfunction. 7 days after the procedure or at the time the patient is discharged from hospital'}, {'measure': 'All-cause mortality', 'timeFrame': 'From baseline to 1, 2, 3 and 6 months after RDN'}, {'measure': 'Severe renal dysfunction (eGFR<15mL/min/m2 or renal function replacement therapy needed)', 'timeFrame': 'From baseline to 6 months after RDN'}, {'measure': 'Rate of new-onset renal artery stenosis assessed (stenosis > 70% )', 'timeFrame': 'From baseline to 2 and 6 months after RDN'}, {'measure': 'AEs, SAEs and severe cardio-cerebrovascular events', 'timeFrame': 'From baseline to1,3 and 6 months after RDN'}], 'primaryOutcomes': [{'measure': 'Change in daytime ASBP', 'timeFrame': 'From baseline to 2 months after RDN', 'description': 'mean change in average daytime ASBP from baseline to 2 months post-procedure.'}], 'secondaryOutcomes': [{'measure': 'Change in office SBP', 'timeFrame': 'From baseline to 1, 2, 3 and 6 months after RDN', 'description': 'Change in Office Systolic BP from baseline to 1 month,2 months,3 months and 6 months post-procedure;'}, {'measure': 'Change in average 24-hr/Night-time Ambulatory BP(Systolic and Diastolic)', 'timeFrame': 'From baseline to 2 months after RDN (for both 24-hr and night-time SBP/DBP); From baseline to 2 months after RDN (for daytime DBP)', 'description': 'change in Average 24-hr/Night-time Ambulatory BP(Systolic and Diastolic) from baseline to 2 months and daytime ambulatory Diastolic BP from baseline to 2 months post procedure'}, {'measure': 'Change in 24-hr Ambulatory BP', 'timeFrame': 'From baseline to 6 months after RDN', 'description': 'Change in 24-hr Ambulatory BP from baseline to 6 months post-procedure'}, {'measure': 'Change in anti-hypertensive Drugs', 'timeFrame': 'From baseline to 1, 2, 3 and 6 months after RDN', 'description': 'Change in anti-hypertensive Drugs form baseline to 1 month、2 months、3 months and 6 months post-procedure;'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertensive Disease']}, 'descriptionModule': {'briefSummary': 'This small-scale, proof-of-concept pilot study aims to obtain preliminary evidence of msRDN procedural safety, feasibility, and short-term efficacy in patients with hypertension without medication therapy, to adequately plan an appropriate pivotal study.', 'detailedDescription': 'This is a prospective, multicenter, single-arm, exploratory study enrolling 15 subjects across approximately four sites with a 6-month follow-up period. Subjects are patients with uncontrolled hypertension who receive 1-2 antihypertensive medications and have completed a minimum two-week medication wash-out period prior to enrollment, or patients with uncontrolled hypertension without medication therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Documented essential hypertension\n3. Resistant or drug-intolerant hypertension, particularly in patients requiring medication reduction\n4. Office BP ≥ 140/90 mmHg and \\< 180/110 mmHg while on a stable regimen of 1-2 antihypertensive medications for ≥ 4 weeks before consent\n5. Documented daytime ASBP ≥ 135 mmHg and \\< 170 mmHg after 2-week washout\n6. Able and willing to comply with all study procedures and follow-up visit\n\nExclusion Criteria:\n\n1.Renal artery anatomy on either side, unsuitable for treatment:\n\n1. Main renal artery diameter \\< 4 mm or \\> 8 mm\n2. Main renal artery length \\< 25 mm\n3. Single functioning kidney\n4. Presence of abnormal kidney (or secreting adrenal) tumors\n5. Renal artery with aneurysm\n6. Pre-existing renal stent or history of renal artery angioplasty\n7. Prior renal denervation procedure\n8. Renal artery stenosis ≥ 50% 2.Active infection within 7 days of procedure 3.Iliac/femoral artery stenosis precluding msRDN catheter insertion 4.Type I diabetes mellitus 5.eGFR \\<45 mL/min/1.73 m2 (by Modification of Diet in Renal Disease formula) 6.Any history of cerebrovascular event (e.g. stroke, transient ischemic event, cerebrovascular accident) 7.Any history of severe cardiovascular event (myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV) 8.Documented confirmed episode(s) of stable or unstable angina 9.Documented repeat (\\> 1) hospitalization for hypertensive crisis within the prior 12 months 10.Chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea 11.Primary pulmonary hypertension 12.Documented contraindication or allergy to contrast medium not amenable to treatment 13.Limited life expectancy of \\< 1 year at the discretion of the Investigator 14.Known drug/alcohol dependence or inability to comply with study protocol Pregnant, breastfeeding or intend to become pregnant within 12 months -'}, 'identificationModule': {'nctId': 'NCT07336433', 'acronym': 'SMART-IC-Pilot', 'briefTitle': 'SMART-IC-Pilot Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'SyMap Medical (Suzhou), Ltd.'}, 'officialTitle': 'EFS Study of the Renal Nerve Mapping/Selective Renal Denervation (msRDN) System in the Absence of Antihypertensive Medications: A Prospective, Multicentre, Single-Arm Exploratory Trial', 'orgStudyIdInfo': {'id': 'SMART-IC-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mapping/Selective Renal Denervation', 'description': 'Mapping/Selective Renal Denervation', 'interventionNames': ['Device: The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II']}], 'interventions': [{'name': 'The SymPioneer G2 Mapping/Selective Renal Denervation Device and SyMapCath Catheter II', 'type': 'DEVICE', 'description': 'Radiofrequency ablation of renal arterial sympathetic nerves', 'armGroupLabels': ['Mapping/Selective Renal Denervation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jie WANG, MD,PHD', 'role': 'CONTACT', 'email': 'jay329329@yahoo.com', 'phone': '+8613511604566'}, {'name': 'JingJing ZHANG, BM', 'role': 'CONTACT', 'email': 'jjzhang@symapmedical.com', 'phone': '+8613914047970'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SyMap Medical (Suzhou), Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}