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Clinical Trial for biodegradable PFO Occluder and Delivery System

Clinical Trial for biodegradable PFO Occluder and Delivery System

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024036
Enrollment
Unknown
Registered
2019-06-23
Start date
2019-06-10
Completion date
Unknown
Last updated
2020-07-27

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

Conditions

patent foramen ovale

Interventions

Case series:Biodegradable PFO occluder and Delivery System

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Clinically diagnosed as having a patent foramen ovale with moderate to large number of right-to-left shunt; (2) Aged = 16 years old; (3) Volunteer to participate in this clinical trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Brain embolism can be found for any reason; (2) Patients with contraindications against platelet or anticoagulant therapy, such as severe bleeding within 3 months, significant retinopathy, a history of intracranial hemorrhage, and significant intracranial disease; (3) Inferior vena cava or pelvic vein thrombosis leads to complete obstruction, systemic or local infection, sepsis, and intracardiac thrombosis; (4) Pregnancy; (5) Combined with pulmonary hypertension or PFO is a special channel; (6) Massive Cerebral Infarction within 4 weeks.

Design outcomes

Primary

MeasureTime frame
Closure success rate;

Secondary

MeasureTime frame
Device success rate;Closure success rate;Overall success rate;Complication rate;

Countries

china

Contacts

Public ContactZhang Yushun

The First Affiliated Hospital of Xi'an Jiaotong University

zys2889@sina.com+86 29 85324078

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026