Preservation of Venous Valvular Function After PMT for Acute DVT

NCT05588284 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: AAL03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

Brief Summary

To evaluate the venous valvular function after pharmacomechanical thrombectomy (PMT) for acute femoral-popliteal venous thrombosis.

Conditions

Acute Deep Venous Thrombosis of Femoral Vein (Disorder)

Outcome Measures

Primary Outcomes (1)

• Valvular reflux prevalence

  Proportion of patients with femoral venous valve reflux at 1 year after procedure

  at 12 months after procedure

Secondary Outcomes (2)

• Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale)

  at 6, 12 and 24 months after procedure

• Patency rate of femopopliteal vein and iliofemoral vein

  at 6, 12 and 24 months after procedure

Study Arms (2)

Pharmacomechanical Catheter-directed Thrombolysis for acute DVT

EXPERIMENTAL

AngioJet, Boston Scientific

Device: AngioJet device

anticoagulation alone for acute DVT

PLACEBO COMPARATOR

anticoagulation alone for acute DVT

Other: anticoagulation alone

Interventions

AngioJet device DEVICE

A device can be used for thrombus aspiration and thrombolysis.

Also known as: Zalente

Pharmacomechanical Catheter-directed Thrombolysis for acute DVT

anticoagulation alone OTHER

a medicine for anticoagulation therapy

Also known as: rivaroxaban

anticoagulation alone for acute DVT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute symptomatic proximal DVT involving the femoral, and/or popliteal vein, common femoral vein, iliac veins (with or without other involved ipsilateral veins) were enrolled at seven vascular centers in China. Patients were treated with PCDT via Zelante device (Boston Scientific).

You may not qualify if:

• Participants were excluded if they had symptoms for more than 14 days.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead
• Boston Scientific Corporation: collaborator

Study Sites (7)

Chuzhou People's Hospital

Chuzhou, Anhui, 238000, China

Location

Center hospital of Putu

Shanghai, Shanghai Municipality, 200011, China

Location

Central Hospital of Songjiang

Shanghai, Shanghai Municipality, 200011, China

Location

North Branch of Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, 200011, China

Location

Shanghai Ninth People's Hospital

Shanghai, Shanghai Municipality, 200011, China

Location

Fengchen Hospital

Shanghai, Shanghai Municipality, 201400, China

Location

Taizhou Municipal hospital

Taizhou, Zhejiang, 218000, China

Location

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kaichuang Ye, MD, PhD

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice professor

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 20, 2022
• Study Start: June 6, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CN (7)