Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT07141251
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094624', 'term': 'Aortic Aneurysm, Thoracoabdominal'}], 'ancestors': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2035-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-30', 'studyFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2025-08-18', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of primary technical success', 'timeFrame': 'within 30 days postoperatively', 'description': 'The preoperative planned protocol was successfully completed, including aneurysm repair and visceral branch reconstruction, with no aneurysm-related conversion to open surgery/death, no type I/III endoleak, and no branch occlusion within 30 days postoperatively.'}, {'measure': 'Incidence of clinical success', 'timeFrame': 'within 5 years postoperatively', 'description': 'The preoperative planned protocol was successfully completed, including aneurysm repair and visceral branch reconstruction, without significant disabling permanent clinical sequelae, and with the patient remained free from aneurysm-related mortality or secondary interventions due to aneurysm progression during follow-up.'}], 'secondaryOutcomes': [{'measure': 'Incidence of aneurysm-related death occurred during perioperative period', 'timeFrame': 'within 30 days postoperatively', 'description': "All deaths occurring before discharge or within 30 days postoperatively that were attributable to the surgical treatment (including stent-induced retrograde dissection, procedure-related aneurysm rupture, branch occlusion causing severe visceral ischemia, etc.) or aneurysm progression, unless there is clear evidence demonstrating the patient's death was unrelated to the aneurysm."}, {'measure': 'Incidence of rupture of aneurysms', 'timeFrame': 'within 5 years postoperatively'}, {'measure': 'Incidence of permanent paraplegia', 'timeFrame': 'within 5 years postoperatively'}, {'measure': 'Incidence of permanent lower limb monoparesis', 'timeFrame': 'within 5 years postoperatively'}, {'measure': 'Incidence of new-onset dialysis-dependent renal failure', 'timeFrame': 'within 5 years postoperatively'}, {'measure': 'Incidence of severe bowel ischemia', 'timeFrame': 'within 5 years postoperatively'}, {'measure': 'Incidence of disabling stroke', 'timeFrame': 'within 5 years postoperatively'}, {'measure': 'Intraoperative blood loss', 'timeFrame': 'during the operation'}, {'measure': 'Incidence of vascular access complications', 'timeFrame': 'within 5 years postoperatively'}, {'measure': 'Operative time', 'timeFrame': 'during the operation'}, {'measure': 'Length of stay (LOS)', 'timeFrame': 'From the date of hospital admission until the date of hospital discharge, assessed up to 5 years'}, {'measure': 'Length of stay for planned staged procedures', 'timeFrame': 'From the date of hospital admission until the date of hospital discharge, assessed up to 5 years'}, {'measure': 'Incidence of adjunctive primary technical success', 'timeFrame': 'within 30 days postoperatively', 'description': 'Required unplanned additional endovascular techniques (e.g., parallel stent-graft technique) to achieve aneurysm exclusion, without type I/III endoleak and with branch patency for 30 days'}, {'measure': 'Incidence of secondary technical success', 'timeFrame': 'within 30 days postoperatively', 'description': 'Required unplanned surgical conversion to complete aneurysm exclusion, without type I/III endoleak and with branch patency for 30 days.'}, {'measure': 'Incidence of stent migration', 'timeFrame': 'within 5 years postoperatively', 'description': 'Definitive stent migration (≥10mm axial displacement) confirmed by evaluation using anatomical landmarks on the first postoperative CT.'}, {'measure': 'Incidence of aneurysm enlargement', 'timeFrame': 'within 5 years postoperatively', 'description': 'Aneurysm enlargement (\\>5mm maximum diameter increase) demonstrated on perioperative and follow-up CTA.'}, {'measure': 'Incidence of significant distal embolization', 'timeFrame': 'within 5 years postoperatively', 'description': 'Stent-induced lower limb arterial embolism with ischemia requiring surgical intervention, amputation, or resulting in death.'}, {'measure': 'Incidence of Stent- or procedure-related exploratory laparotomy', 'timeFrame': 'within 5 years postoperatively', 'description': 'Adverse event requiring exploratory laparotomy due to stent- or procedure-related complications'}, {'measure': 'Incidence of aortoiliac stent occlusion', 'timeFrame': 'within 5 years postoperatively', 'description': 'Occlusion of aortic branch stents, iliac branch devices, or iliac limb extensions'}, {'measure': 'Rate of primary stent patency', 'timeFrame': 'within 5 years postoperatively', 'description': 'Patency of branch stents and bridging stents, with no in-stent restenosis or occlusion.'}, {'measure': 'Rate of adjunctive primary stent patency', 'timeFrame': 'within 5 years postoperatively', 'description': 'Secondary intervention was required due to branch/bridging stent kinking or in-stent restenosis, with patency restored after the additional procedure.'}, {'measure': 'Rate of secondary stent patency', 'timeFrame': 'within 5 years postoperatively', 'description': 'Patency restored after secondary intervention for branch/bridging stent occlusion.'}, {'measure': 'Incidence of reoperation', 'timeFrame': 'within 5 years postoperatively', 'description': 'Unplanned reoperation related to stent or procedure within the intended treatment zone, excluding access-related reinterventions and procedures outside the target anatomical area.'}, {'measure': 'Incidence of acute kidney injury', 'timeFrame': 'within 30 days postoperatively', 'description': 'A perioperative increase in serum creatinine to 1.5-2 times the preoperative baseline value according to RIFLE criteria.'}, {'measure': 'Incidence of Type I endoleak', 'timeFrame': 'within 5 years postoperatively', 'description': 'Endoleak originating from proximal or distal seal zones'}, {'measure': 'Incidence of Type Ia endoleak', 'timeFrame': 'within 5 years postoperatively', 'description': 'Endoleak originating from the proximal seal zone of aortic stent'}, {'measure': 'Incidence of Type Ib endoleak', 'timeFrame': 'within 5 years postoperatively', 'description': 'Endoleak originating from the distal seal zone of aortic or iliac stents'}, {'measure': 'Incidence of Type Ic endoleak', 'timeFrame': 'within 5 years postoperatively', 'description': 'Endoleak originating from the distal seal zone of visceral artery stents'}, {'measure': 'Incidence of Type II endoleak', 'timeFrame': 'within 5 years postoperatively', 'description': 'Endoleak originating from aortic branches (e.g., inferior mesenteric artery, lumbar arteries, intercostal arteries)'}, {'measure': 'Incidence of Type III endoleak', 'timeFrame': 'within 5 years postoperatively', 'description': 'Endoleak originating from stent junctions or device structural failure'}, {'measure': 'Incidence of Type IIIa endoleak', 'timeFrame': 'within 5 years postoperatively', 'description': 'Endoleak due to aortoiliac stent junctional failure'}, {'measure': 'Incidence of Type IIIb endoleak', 'timeFrame': 'within 5 years postoperatively', 'description': 'Endoleak caused by fracture or disruption of visceral artery stents within branch vessels'}, {'measure': 'Incidence of Type IIIc endoleak', 'timeFrame': 'within 5 years postoperatively', 'description': 'Endoleak into the aortic aneurysm sac due to poor connection or structural failure between visceral branch bridging stents and aortic branch stents'}, {'measure': 'Incidence of Type IV endoleak', 'timeFrame': 'within 5 years postoperatively', 'description': 'Endoleak due to stent-graft fabric permeability'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BAO-G technique', 'iliac-branched devices', 'endovascular repair', 'complex aortic aneurysm'], 'conditions': ['Thoracoabdominal Aortic Aneurysm', 'Endovascular Repair', 'Complex Aortic Aneurysms']}, 'descriptionModule': {'briefSummary': 'Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique is a novel technique of endovascular repair of complex aortic aneurysm, which using off-the-shelf iliac branched devices to reconstruct the visceral branches. This study aims to verify the perioperative safety and 5-year efficacy of BAO-G technique in the endovascular treatment of complex aortic aneurysms through a prospective, multicenter, open-label, single-arm clinical trial, and to provide evidence for the selection of clinical procedures for complex aortic aneurysm patients in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with Crawford type III-IV thoracoabdominal aortic aneurysm or complex abdominal aortic aneurysm, with a healthy proximal landing zone (\\>20mm length, angulation \\<60°) in the descending aorta and maximum aneurysm diameter ≥4cm\n2. Scheduled for endovascular aortic repair with commercially available iliac branch devices for visceral artery reconstruction\n3. Signed informed consent and committed to protocol-defined follow-up\n\nExclusion Criteria:\n\n1. Acquired language barrier, intellectual decline, cognitive impairment, or mental illness preventing informed consent\n2. Uncontrolled autoimmune diseases (e.g., Takayasu arteritis, systemic lupus erythematosus, vasculitis)\n3. Prior aortic surgery with stent-graft or prosthetic vascular graft implantation\n4. End-stage renal/hepatic/cardiac/pulmonary failure or malignancy diagnosed within 5 years, likely to cause mortality during follow-up\n5. Active bleeding or coagulopathy within 6 months (high bleeding risk)\n6. Uncontrolled hypertension (resting SBP \\>180 mmHg or DBP \\>110 mmHg)\n7. Uncontrolled diabetes (fasting blood glucose \\>16.7 mmol/L)\n8. Severe hepatic/renal dysfunction (serum creatinine \\>3 mg/dL, ALT/AST \\>3×ULN)\n9. Concurrent participation in other interventional clinical trials\n10. Pregnancy or perinatal status\n11. Refusal to sign informed consent'}, 'identificationModule': {'nctId': 'NCT07141251', 'acronym': 'BAO-G-02', 'briefTitle': 'Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Multicenter, Open-labeled, Single-arm Clinical Trial of Multi-Branch AOrtic Reconstruction of Complex Aortic Aneurysm With G-iliac System [BAO-G] Technique', 'orgStudyIdInfo': {'id': 'BAO-G-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAO-G group', 'interventionNames': ['Procedure: BAO-G']}], 'interventions': [{'name': 'BAO-G', 'type': 'PROCEDURE', 'description': 'Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.', 'armGroupLabels': ['BAO-G group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Beijing Anzhen Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Fuwai Hospital, CAMS&PUMC', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bao Liu', 'role': 'CONTACT', 'email': 'liubao7286@163.com', 'phone': '+86010-69152592'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The First Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '570311', 'city': 'Haikou', 'state': 'Hainan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Hainan General Hospital', 'geoPoint': {'lat': 20.03421, 'lon': 110.34651}}, {'zip': '450052', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '272000', 'city': 'Jining', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The Affiliated Hospital of Jining Medical University', 'geoPoint': {'lat': 35.405, 'lon': 116.58139}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Zhongshan Hospital, Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Renji Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Bao Liu', 'role': 'CONTACT', 'email': 'liubao7286@163.com', 'phone': '+86010-69152592'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fudan University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Changhai Hospital', 'class': 'OTHER'}, {'name': 'Chinese Academy of Medical Sciences, Fuwai Hospital', 'class': 'OTHER'}, {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, {'name': 'RenJi Hospital', 'class': 'OTHER'}, {'name': 'Hainan General Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, {'name': 'The Affiliated Hospital of Jining Medical University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}