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Treatment for acute left lower extremity deep vein thrombosis combined with iliac vein stenosis with catheter-directed thrombolysis concurrent with iliac vein stent: a prospective, multicenter clinical trial

Treatment for acute left lower extremity deep vein thrombosis combined with iliac vein stenosis with catheter-directed thrombolysis concurrent with iliac vein stent: a prospective, multicenter clinical trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-15006867
Enrollment
Unknown
Registered
2015-07-29
Start date
2015-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Acute left lower extremity deep vein thrombosis

Interventions

A:balloon-assisted catheter directed thrombolysis, stents will be implanted after thrombosis completely dissolved
B:balloon-assisted catheter directed thrombolysis, stent will be implanted simultaneously.

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Men and women between 18–75 years of age; (2) Symptoms last for less than 14 days(patients with history of lower limb swelling should be excluded); (3) Definite diagnosis of left lower extremity deep vein thrombosis(central or mixed type) combined with iliac vein stenosis by ultrasonography or angiography. Complementary inclusion: iliac vein stenosis diagnosed by balloon dilatation; (4) Patients understand the nature of the procedure, cooperate with follow-up, and provide written informed consent before enrollment in the study.

Exclusion criteria

Exclusion criteria: (1) Patients with anticoagulation of more than 7 days; (2) Patients with uncorrected bleeding disorders (portal hypertension, gastrointestinal bleeding, gastrointestinal ulcer); (3) Hemoglobin < 8 g/dL; (4) Platelet < 80*10^9/L; (5) Severe renal failure, Ccr < 30ml/min; (6) Severe hypertension (diastolic blood pressure greater than 100 mm Hg, systolic blood pressure greater than 160 mm Hg); (7) DVT complicating pregnancy or with recent (<14 days) childbirth; (8) Women with child-bearing potential should be confirmed unpregnant by urine pregnancy test; (9) Patients with recent (<14 days) major surgery or trauma; (10) Patients with recent (<3 months) subdural hemorrhage or intracranical hemorrhage; (11) Life expectancy of less than 24 months; (12) Patients with a history of homolateral DVT; (13) Patients with an extensive iliac vein stenosis or stale thrombus in the secondary enrollment.

Design outcomes

Primary

MeasureTime frame
Rate of lower extremity swelling relief;Rate of vein patency;Post-thrombotic syndrome;VEINES-QOL/Sym questionnaire;Dosage of urokinase;Time of thrombolysis catheter indwelling (treatment time);Hospitalization expenses;

Countries

China

Contacts

Public ContactNi Caifang
cjr.nicaifang@vip.163.com+86 13706200115

Outcome results

None listed

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