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

U

University of Toledo Health Science Campus

Status and phase

Withdrawn
Phase 4

Conditions

Deep Venous Thrombosis
Post Thrombotic Syndrome

Treatments

Drug: Anticoagulation
Combination Product: Catheter directed thrombolysis plus anticoagulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04411316
300439

Details and patient eligibility

About

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.

Full description

Patients with Iliofemoral DVT are theoretically at the highest risk for development of PRS given involvement of the major drainage pathway of both superficial femoral and deep femoral veins. This would not only affect the primary venous drainage, but would also compromise the ability to develop efficient collateral pathways. This creates higher chances of developing post-thrombotic syndrome (PTS). The proposed trial would utilize Angiojet thrombectomy followed by catheter directed thrombolysis and Anticoagulation compared to Anticoagulation alone. To assess whether Pharmacomechanical catheter-directed thrombolysis (PCDT) therapy utilizing AngioJet and tPA for the treatment of iliofemoral deep venous thrombosis can safely and effectively reduce post thrombotic syndrome after 24 months.

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Pharmacomechanical thrombolysis plus anticoagulation
Experimental group
Description:
This group of patients will receive Pharmacomechanical catheter-directed thrombolysis (PCDT) plus Anticoagulation. PCDT will be AngioJet along with alteplase. Anticoagulation will be heparin only
Treatment:
Combination Product: Catheter directed thrombolysis plus anticoagulation
Anticoagulation
Active Comparator group
Description:
This group of patients will receive standard anticoagulation only. Anticoagulation will be Heparin only
Treatment:
Drug: Anticoagulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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