Peripheral vascular disease (build the vascular access)
Conditions
Interventions
Group A:Fustar steerable introducer applied to intervention
Group B:Cook vascular sheath applied to interventional procedures
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Complying with the standard of peripheral vascular interventional operation treatment of peripheral vascular disease; 2. The need to establish vascular interventional treatment channel, so that the devices (stent, balloon, guide wire, etc.)can reach the target vessel (including but not limited to the contralateral iliac artery, femoral artery, the Visceral Arteries, subclavian artery, carotid artery,abdominal aortic aneurysm stents of the contralateral limb and the following branches); 3. Aged 18 to 80 years old; 4. The patient who is able to understand the test purpose, voluntarily join this clinical trial with informed consent forms.Remarks: (1) Visceral Arteries: the superior mesenteric artery, renal artery, celiac artery.
Exclusion criteria
Exclusion criteria: 1. Not suitable for patients who undergone a vascular interventional operation treatment; 2. Patients with cerebrovascular accident or major gastrointestinal bleeding in six months unable to carry out antithrombotic therapy because of having contraindications to antiplatelet agents and anticoagulants and have haemorrhage tendency; 3. Hypohepatia, hematuria, deep vein thrombosis, and/or receiving the immunosuppressant therapy 4. The distal target vessel blood flow low may produce thrombosis; 5. The women who pregnancy, lactation and can't contraception during the trial period; 6. Patients has been involved in other drugs or medical devices clinical trials related to treatment of the target lesion or has been involved in other drugs or medical device clinical trials but have not reached the primary endpoint of the study; 7. Patients unable or unwilling to participate in this trial or the researcher determine the patient is not suitable to participate in clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success of introducer usage; | — |
Secondary
| Measure | Time frame |
|---|---|
| introducer's compliance;introducer's directivity;introducer's development;hematischesis, laboratory examination and adverse event; | — |
Countries
China
Contacts
Public ContactWeiguo FU
Outcome results
None listed