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Evaluation of the safety and effecacy of single-branched stent graft for management of type B dissections involving the left subclavian artery

Evaluation of the safety and effecacy of single-branched stent graft for management of type B dissections involving the left subclavian artery: A prospective, single center and randomized control study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031662
Enrollment
Unknown
Registered
2020-04-06
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type B Aortic Dissection

Interventions

control group:Life-tech stent graft combined with fenestrated/chimney technique
Experimental group:single-branched stent graft

Sponsors

The Second Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-85 years old, male or non pregnant female; 2. Patients with proximal rupture between 15 mm distal to the left common carotid artery and 20 mm distal to the left subclavian artery; 3. The patients whose dissection is reversed to the dissection of the left subclavian artery; 4. Patients with clinical symptoms related to aortic dissection, such as persistent pain in the chest and back, uncontrolled hypertension, etc; 5. Patients with type B aortic dissection (acute or non acute stage) confirmed by imaging, including penetrating ulcer and intramural hematoma; 6. The imaging examination shows that the patients with hematoma in mediastinum or around the aorta, the involvement of branches and arteries caused the ischemia of important organs, the progress of dissection (the diameter of dissection increased rapidly, >=5mm/3 months), or tumor like dilation (the diameter of aorta >=40mm), and the rupture of dissection; 7. Patients who are willing to complete the clinical study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with dissection involving zone 0 or zone 1 or ascending aorta dilation; 2. Patients with cardiopulmonary or hepatorenal insufficiency who cannot tolerate tracheal intubation; 3. Patients diagnosed as connective tissue disease; 4. Patients who are allergic to nichrome or iodized contrast agents; 5. Patients with uncontrollable infection; 6. Patients with coagulation dysfunction that is difficult to correct; 7. Patients with severe stenosis of bilateral common femoral artery; 8. Patients who are unable to cooperate with the operation or who have not signed the preoperative informed consent.

Design outcomes

Primary

MeasureTime frame
perioperative complications;

Secondary

MeasureTime frame
the remodeling of aorta;aorta related events;patency of the LSA and LCCA;3-year and 5-year all cause and aorta related mortality;3-year and 5-year all cause and aorta related mortality;technical success rate;

Countries

China

Contacts

Public ContactYuliang Li

Department of intervention medicine, the Second Hospital of Shandong University

lyl.pro@sdu.edu.cn+86 15153169899

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026