Catheter-directed Thrombolysis Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis

• Status: Withdrawn
• Trial end date: 2022-12-19
• Target enrollment: 0
• Participant gender: All

Summary

Post-thrombotic syndrome (PTS) is a complication that can develop after deep vein thrombosis (DVT) of the lower extremities. PTS can occur at various times after the initial episode, but usually manifests within two years of initial DVT onset. Early and more complete thrombus clearance is believed by many to relieve venous outflow obstruction, preserve valvular function and reduce venous hypertension. Two previously published randomized controlled trials, the CAVENT trial and the ATTRACT trial, were larger and designed to investigate the efficacy of CDT. However, both of these trials included patients with iliofemoral as well as femoro-popliteal deep vein thrombosis. Our study will be limited to patients with iliofemoral deep vein thrombosis to assess whether Pharmacomechanical catheter-directed thrombolysis (PCDT) therapy utilizing AngioJet and tPA can safely and effectively reduce post thrombotic syndrome after 24 months.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Toledo Health Science Campus

Criteria

Inclusion Criteria:

1. Age>18 and younger than 75

2. Symptomatic, proximal deep-vein thrombosis involving the Iliofemoral vein from 12/01/2019 to 12/01/2022

Exclusion Criteria:

1. Age less than 18 years or greater than 75 years.

2. Symptom duration > 14 days for the DVT episode in the index leg (i.e. non-acute DVT).

3. In the index leg: established PTS, or previous symptomatic DVT within the last 2 years.

4. In the contralateral (non-index) leg: symptomatic acute DVT a) involving the popliteal and/or tibial veins; or b) for which thrombolysis is planned as part of initial therapy.

5. Limb-threatening circulatory compromise.

6. PE with hemodynamic compromise (i.e. hypotension).

7. Inability to tolerate PCDT procedure due to severe dyspnea or acute systemic illness.

8. Allergy, hypersensitivity, or thrombocytopenia from heparin, rt-PA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.

9. Hemoglobin < 9.0 mg/dl, INR > 1.6 before warfarin was started, or platelets < 100,000 /ml.

10. Moderate renal impairment in diabetic patients (estimated GFR < 60 ml/min) or severe renal impairment in non-diabetic patients (estimated GFR < 30 ml/min).

11. Active bleeding, recent (< 3 months) GI bleeding, severe liver dysfunction, bleeding diathesis.

12. Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy; recent (< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.

13. History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.

14. Active cancer (metastatic, progressive, or treated within the last 6 months). Exception: patients with non-melanoma primary skin cancers are eligible to participate in the study.

15. Severe hypertension on repeated readings (systolic > 180mmHg or diastolic > 105 mmHg).

16. Pregnant (positive pregnancy test, women of childbearing potential must be tested).

17. Recently (< 2 years or chronic non-ambulatory status.

18. Use of a thienopryridine antiplatelet drug (except clopidogrel) in the last 5 days.

19. Life expectancy < 2 years or chronic non-ambulatory status.

20. Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).