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A prospective, multicenter, randomized controlled trial for determination of the safety and efficacy of kpin

A prospective, multicenter, randomized controlled trial for determination of the safety and efficacy of kpin

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023794
Enrollment
Unknown
Registered
2019-06-12
Start date
2018-08-01
Completion date
Unknown
Last updated
2019-06-17

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

Conditions

Arteriovenous malformations

Interventions

Group B:Coil
Group A:kpin

Sponsors

Xinhua Hospital Affiliated To Shanghai Jiaotong University School Of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects and/or their legal guardians will be informed of the nature of this study and agree to participate in this clinical trial in accordance with all terms of this study.Signed the informed consent approved by the ethics committee, agreed to accept the postoperative treatment program, and completed the follow-up and related examinations as required by the follow-up; 2. At least one somatopulmonary collateral branch that needs to be occluded, and the blood vessel diameter at the occluded site should be =2mm,=5mm.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to general angiography; 2. Cases of severe dysfunction of important organs (liver and kidney) and patients with coagulation dysfunction are known; 3. The exclusion criteria for the abnormal access of pulmonary collateral vessels were as follows: a. the collateral vessels of the local pulmonary segment supplied with blood alone should not be embolized in principle to avoid pulmonary infarction;b. For those who found or considered the collateral vessels of body pulmonary artery involved in spinal cord blood supply, embolization cannot be performed to avoid the occurrence of paraplegia;c. For the extremely specific and curved origin, the researchers judged that the side branches that could not be located accurately at the end of the catheter could not be embolized to prevent the delivery device from reaching the target vessel;d. The diameters of the pulmonary collateral vessels to be occluded were all 5mm; 4. Laboratory examination: a. hematological abnormalities (WBC 3.0 mg/dl) and/or advanced renal disease require renal dialysis; 5. Device related: known allergy or contraindication to Nitinol, heparin; 6. Pregnancy or planned pregnancy during the course of this study (for women of reproductive age only); 7. During the first 30 days of screening, participants participated in clinical trials of other drugs or medical devices; 8. Not suitable for treatment with this product.

Design outcomes

Primary

MeasureTime frame
Immediate success rate;

Countries

China

Contacts

Public ContactKun Sun

Xinhua Hospital Affiliated To Shanghai Jiaotong University School Of Medicine

drsunkun@xinhuamed.com+86 021-25078999

Outcome results

None listed

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