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A prospective, multicenter, randomized controlled clinical trial for evaluation of the safety and effectiveness of MAIHE occlusion hemostasis system and ExoSeal occlusion hemostasis system in femoral artery puncture hemostasis

Prospective, multicenter, randomized controlled clinical trial for evaluation of the safety and effectiveness of MAIHE occlusion hemostasis system and ExoSeal occlusion hemostasis system in femoral artery puncture hemostasis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021586
Enrollment
Unknown
Registered
2019-02-28
Start date
2019-02-12
Completion date
Unknown
Last updated
2019-03-04

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

Conditions

Transfemoral puncture

Interventions

Group 1:hemostasis system
Group 2:ExoSeal hemostasis system

Sponsors

Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years, male or infertile female; 2. Patients who underwent angiography or interventional surgery through femoral artery puncture; 3. Angiography or interventional surgery using 5-7F guided sheath with length less than 12 cm; 4. Subjects or their legal guardians volunteered to participate in the experiment and signed a written consent.

Exclusion criteria

Exclusion criteria: 1. Common femoral artery occlusion or visual lumen diameter less than 5 mm; 2. ST-segment elevation myocardial infarction within 48 hours before intervention; 3. Patients with uncontrollable hypertension during occlusion (blood pressure (> 180/110 mm Hg); 4. Patients with symptomatic ischemia of the limbs and legs of the target vessel, or with femoral artery surgery or vascular transplantation of the target vessel; 5. Preoperative activated partial thromboplastin time (APTT) > upper limit of normal value + 10 seconds; 6. Patients receiving thrombolytic therapy (e.g. streptokinase, urokinase, t-PA) less than 24 hours before closure of blood vessels; 7. Patients who received bivalirudine or low molecular weight heparin within 24 hours before puncture; 8. Patients requiring bilateral femoral artery puncture; 9. Patients with target femoral artery puncture within 30 days before interventional therapy; 10. In patients with visible calcification, atherosclerotic disease or stent implantation, the distance between stent implantation and puncture point is less than 1 cm; 11. Suffer from systemic infection or skin infection; 12. To study the lower extremity arteriosclerosis obliterans and not suitable for femoral artery puncture; 13. Patients with anterograde femoral artery puncture; 14. Women in pregnancy or lactation or men or women with fertility plans in the next six months.

Design outcomes

Primary

MeasureTime frame
Instrument success rate;

Countries

China

Contacts

Public ContactLiqun Jiao

Xuanwu Hospital, Capital Medical University

13911224991@139.com+86 13911224991

Outcome results

None listed

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