Pharmacomechanical Catheter-directed Thrombolysis (PCDT) Plus Anticoagulation Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis:
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Post-thrombotic syndrome at any time between 6-month and 24-month.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age>18 and younger than 75
- •Symptomatic, proximal deep-vein thrombosis involving the Iliofemoral vein from 12/01/2019 to 12/01/2022
排除标准
- •Age less than 18 years or greater than 75 years.
- •Symptom duration > 14 days for the DVT episode in the index leg (i.e. non-acute DVT).
- •In the index leg: established PTS, or previous symptomatic DVT within the last 2 years.
- •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.
- •Limb-threatening circulatory compromise.
- •PE with hemodynamic compromise (i.e. hypotension).
- •Inability to tolerate PCDT procedure due to severe dyspnea or acute systemic illness.
- •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.
- •Hemoglobin < 9.0 mg/dl, INR > 1.6 before warfarin was started, or platelets < 100,000 /ml.
- •Moderate renal impairment in diabetic patients (estimated GFR < 60 ml/min) or severe renal impairment in non-diabetic patients (estimated GFR < 30 ml/min).
- •Active bleeding, recent (< 3 months) GI bleeding, severe liver dysfunction, bleeding diathesis.
- •Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy; recent (< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.
- •History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
- •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.
- •Severe hypertension on repeated readings (systolic > 180mmHg or diastolic > 105 mmHg).
- •Pregnant (positive pregnancy test, women of childbearing potential must be tested).
- •Recently (< 2 years or chronic non-ambulatory status.
- •Use of a thienopryridine antiplatelet drug (except clopidogrel) in the last 5 days.
- •Life expectancy < 2 years or chronic non-ambulatory status.
- •Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).
研究组 & 干预措施
Pharmacomechanical thrombolysis plus anticoagulation
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
干预措施: Catheter directed thrombolysis plus anticoagulation (Combination Product)
Anticoagulation
This group of patients will receive standard anticoagulation only. Anticoagulation will be Heparin only
干预措施: Anticoagulation (Drug)
结局指标
主要结局
Post-thrombotic syndrome at any time between 6-month and 24-month.
时间窗: 6-24 months
Occurrence of post-thrombotic syndrome at any time between 6-month and 24-month after procedure by Villata score (Villata score \>5 or more), or if patient underwent an unplanned endovascular procedure to treat venous symptoms. The variables in villata scores are pain, cramps, heaviness, parasthesia, pruritus, pretibial edema, skin induration, hyperpigmentation, pain during calf compression, venous ectasia and redness. The Villata score ranges 0-45. Villata score \<5 means no post-thrombotic syndrome. Villata score 5-9 mild post-thrombotic syndrome. Villata score 10-14 means moderate post-thrombotic syndrome. Villata score ≥15 or presence of an ulcer indicates severe post-thrombotic syndrome. The more is the score the worse is the disease.
次要结局
- Post-thrombotic syndrome at 6 months.(6 months)
- Post-thrombotic syndrome at 12 months.(12 months)
- Post-thrombotic syndrome at 18 months.(18 months)
- Post-thrombotic syndrome at 24 months.(24 months)
- Villalta scale at 6 months(6 months)
- Villalta scale at 12 months(12 months)
- Villalta scale at 18 months(18 months)
- Villalta scale at 24 months(24 months)
- Venous Clinical Severity Score at 6 months(6 months)
- Venous Clinical Severity Score at 12 months(12 months)
- Venous Clinical Severity Score at 18 months(18 months)
- Venous Clinical Severity Score at 24 months(24 months)
- Health-Related Quality of Life AT 6 months(6 months)
- Health-Related Quality of Life at 12 months.(12 months)
- Health-Related Quality of Life at 18 months.(18 months)
- Health-Related Quality of Life at 24 months.(24 months)
- Health-Related Quality of Life at 6 months.(6 months)
- Treatment Failures that are Not PTS.(6-24 months)
- Severity of presenting DVT Symptoms at 6 months(6 months)
- Severity of presenting DVT Symptoms at 12 months(12 months)
- Severity of presenting DVT Symptoms at 18 months(18 months)
- Severity of presenting DVT Symptoms at 24 months(24 months)
- Degree of Resolution of Thrombus with PCDT at 6 months.(6 months)
- Degree of Resolution of Thrombus with PCDT at 12 months.(12 months)
- Degree of Resolution of Thrombus with PCDT at 18 months.(18 months)
- Degree of Resolution of Thrombus with PCDT at 24 months.(24 months)
研究者
Ehab Eltahawy, MD
Associate professor of Medicine
University of Toledo Health Science Campus