Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting

NCT ID: NCT04694248

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-03
• Study Completion Date: 2027-06-30

Brief Summary

To evaluate the efficacy and safety of combination of anticoagulant and antiplatelet therapy on the patency of iliac vein at 12-month post stenting in patients with acute proximal DVT and ipsilateral iliac vein stenosis who received percutaneous mechanic thrombectomy and iliac vein stenting.

Detailed Description

This study is a single-arm, prospective, open-label, multicenter study conducted in the Zhejiang Province, China. Randomized controlled trial is not an optimum option at this stage given the lack of high-quality data in terms of this hypothesis. Eligible subjects will include men and women with age of 18 years or older, who have a confirmed diagnosis of acute proximal DVT with ipsilateral iliac vein stenosis. A total of 172 subjects will be enrolled. The inclusion criteria and exclusion criteria are pre-defined. Subjects meeting all inclusion and no exclusion criteria will be eligible for enrollment. All subjects will receive the combination of anticoagulant and antiplatelet therapy after implanted with iliac vein stent. For anticoagulant, it is rivaroxaban 20mg once a day for 6 months. For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.The duration of study participation for each subject is 12 months. Each subject will be followed at 3 months, 6 months and 12 months post-procedure. Efficacy endpoints and safety endpoints will be documented during the follow-up. After completing the follow-up, data will be analyzed.

Conditions

Deep Vein Thrombosis; Iliac Vein Thrombosis; Iliac Vein Obstruction; Iliac Vein Stenosis; Iliac Vein Compression Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anticoagulant plus antiplatelet therapy

For anticoagulant, it is rivaroxaban 20mg once a day for 6 months. For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.

Group Type: EXPERIMENTAL

Rivaroxaban

Intervention Type: DRUG

For anticoagulant, it is rivaroxaban 20mg once a day for 6 months.

Aspirin

Intervention Type: DRUG

For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.

Interventions

Rivaroxaban

For anticoagulant, it is rivaroxaban 20mg once a day for 6 months.

Intervention Type: DRUG

Aspirin

For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.

Intervention Type: DRUG

Other Intervention Names

Anticoagulant; Antiplatelet

Eligibility Criteria

Inclusion Criteria

IC1. Subjects who were diagnosed with deep venous thrombus (DVT) with ipsilateral iliac venous stenosis (>50%). The ipsilateral iliac venous stenosis can be caused either by iliac vein compression (i.e. Cockett syndrome) or residue iliac venous thrombus after percutaneous mechanic thrombectomy.

IC2. Subjects who accepted percutaneous mechanic thrombectomy (PMT) to decrease the burden of thrombus, with or without catheter directed thrombolysis (CDT).

IC3. Subjects who accepted iliac venous stent(s) implantation during the perioperative period of PMT or CDT (≤30 days post PMT or CDT) .

Exclusion Criteria

EC1. Subject has chronic DVT or the onset of DVT is longer than 3 weeks, or chronic DVT.

EC2. Subject has isolated distal DVT, which does not affect ipsilateral femoral or iliac vein.

EC3. Subject has glomerular filtration rate < 60ml/min. EC4. Subject has ipsilateral varicose vein or suffers from ipsilateral venous insufficiency prior to the DVT. The manifestations of venous insufficiency include skin pigmentation, edema, lipodermatosclerosis and venous ulcer.

EC5. Subject has acute arterial embolism on either side or suffers from known moderate or greater stenosis at abdominal aorta, ipsilateral iliac artery and ipsilateral lower extremity artery.

EC6. Subject has known aneurysm(s) or current limiting dissection at abdominal aorta, ipsilateral iliac artery and ipsilateral lower extremity artery.

EC7. Subject has contraindication to antiplatelet drugs or anticoagulants. EC8. Subject has systemic disease(s) that cannot be treated by current medicine.

EC9. Subject has been taking anticoagulants or antiplatelet drugs for other diseases prior to the DVT.

EC10. Subject less than 18 years old or rejected to join this study. EC11. Subject has myocardial infarction during the past 6 months. EC12. EC12. Subject who is at high bleeding risk*.

• Subject who has at least one of the below conditions will be considered at high bleeding risk: Primary history of intracerebral haemorrhage or ischemic stroke, history of other intracranial pathology, recent gastrointestinal bleeding or anaemia due to possible gastrointestinal blood loss, other gastrointestinal pathology associated with increased bleeding risk, liver failure, bleeding diathesis or coagulopathy, extreme old age or frailty, or renal failure requiring dialysis or with eGFR <15ml/min/1.73 m2.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: collaborator

Ningbo No.2 Hospital

OTHER

Sponsor Role: collaborator

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

OTHER

Sponsor Role: collaborator

The Central Hospital of Lishui City

OTHER

Sponsor Role: collaborator

Taizhou Enze Medical Center Group

OTHER

Sponsor Role: collaborator

Taizhou First People's Hospital

OTHER

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Hongkun Zhang, MD

Chief of Department of Vascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongkun Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

The First Affliated Hospital, Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongkun Zhang, M.D.

Role: CONTACT

1198050@zju.edu.cn

0571-87236745

Facility Contacts

Hongkun Zhang

Role: primary

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Other Identifiers

IIT20200040C

Identifier Type: -

Identifier Source: org_study_id