Introducer Curving Technique for Tilt of Transfemoral Günther Tulip Inferior Vena Cava Filter

China Medical University, China

Status: Completed

Conditions: Deep Venous Thrombosis

Treatments: Device: curving introducer Günther Tulip Filter; Device: straight introducer Günther Tulip Filter

Study type: Interventional

Funder types: Other

Identifiers

NCT01333618

LXiao-01

Details and patient eligibility

About

It has been demonstrated that implantation of inferior vena cava filter was safe and effective in the prevention or reduction of fatal pulmonary thromboembolism in numerous clinical researches. When acute deep venous thrombosis need transcatheter thrombolysis, transfemoral Günther Tulip Filter implantation could avoid catheter across the Günther Tulip Filter. Although incidence of significant filter tilting (>10°) is not high (13%-16%), severe tilting of the Günther Tulip Filter may be associated with difficulty or sometimes impossibility of retrieval. It has been reported that a simple technique of keeping tension of the delivery system may prevent significant tilting of the transjugular Günther Tulip Filter in an in-vitro study. But no clinical study of prevention transfemoral Günther Tulip Filter from tilting has been reported. The investigators conducted a randomized, controlled study to test whether the introducer curving technique is useful to decrease the extent of tilting of transfemoral Günther Tulip Filter.

Full description

The study was designed as a double-blind randomized controlled trial, with research assessors and patients intended to be blind to the intervention status. The staff members performing the assessment were not involved in implementing any aspect of the intervention. 108 patients were randomized to accept curving introducer Günther Tulip Filter and transcatheter thrombolysis or straight introducer Günther Tulip Filter and transcatheter thrombolysis. The assessments include the tilting angle between the axes of inferior vena cava and Günther Tulip Filter after implantation; the tilting angle between the axes of inferior vena cava and Günther Tulip Filter before retrieval; the fluoroscopy time of Günther Tulip Filter retrieval; the rate of retrieval hook adhering vascular wall; the success rate of retrieval.

Enrollment: 108 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• acute lower extremity deep vein thrombosis, diagnosed by vascular ultrasound and clinical history

Exclusion criteria

• both lower extremities deep vein thrombosis
• Inferior Vena Cava thrombosis
• refractory hypertension (blood pressure > 180/110mmHg)
• contraindication of thrombolysis
• the diameter of Inferior Vena Cava > 35mm or < 14mm
• Inferior Vena Cava venous anomalies

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 2 patient groups, including a placebo group

curving introducer

Experimental group

Treatment:

Device: curving introducer Günther Tulip Filter

straight introducer

Placebo Comparator group

Treatment:

Device: straight introducer Günther Tulip Filter