Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy - The C-TRACT Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 225
- 试验地点
- 41
- 主要终点
- PTS Severity
研究概览
简要总结
The purpose of this study is to determine if the use of image-guided, endovascular therapy (EVT) is an effective strategy with which to reduce Post Thrombotic Syndrome (PTS) disease severity and improve quality of life in patients with established disabling iliac-obstructive post thrombotic syndrome (DIO-PTS).
详细描述
The rationale for performing the C-TRACT Trial is based upon:
- the debilitating life impact of DIO-PTS upon patients, as cited in the U.S. Surgeon General's 2008 Call to Action on DVT (95);
- the inability of existing therapies to prevent or alleviate most cases of DIO-PTS;
- the role of iliac vein obstruction and saphenous reflux in causing the severe manifestations of DIO-PTS;
- the ability of stent placement and endovenous ablation to eliminate obstruction and reflux, respectively, to reduce PTS severity, and to improve QOL in preliminary studies;
- the risks, costs, and uncertainties of this novel but invasive strategy;
- the lack of consensus on whether EVT should be used for DIO-PTS;
- the motivation of our established investigator team to answer this critical clinical question.
We will determine if EVT should be routinely used to treat DIO-PTS. If so, this finding will fundamentally change DIO-PTS practice towards more frequent use of EVT. If EVT proves ineffective or unsafe, this finding will reduce or eliminate the use of potentially risky and expensive procedures.
250 subjects with established DIO-PTS will be randomized in a 1:1 ratio to either EVT or No-EVT treatment groups. All participants will receive standard PTS therapy. Subjects will be enrolled over approximately 36 months in 20-40 U.S. Participants enrolled in C-TRACT protocol versions prior to 5.0 will be followed for 24 months. Subjects enrolled on protocol version 5.0 or after will be followed for 6 months. The study will take approximately 6 years to complete.
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
- Single (Outcomes Assessor)
盲法说明
PTS is assessed at the 6-month follow-up visit. The examiner must be a study-designated blinded clinician (MD, RN, APRN, or PA) who has completed study-specific PTS training to standardize across sites. PTS examiners must be blinded to participant treatment arm allocation. Subjects are reminded to not reveal to clinic staff which therapy they received (EVT or No-EVT). Subjects should be examined in the afternoon to allow the symptoms and signs of PTS to manifest.
- The subject should be asked to rate the symptoms on the Villalta PTS scale for each leg, record his/her ratings, and complete the QOL questionnaires.
- The subject's legs should be unclothed and he/she should be seated facing the blinded clinician examiner. Without access to the subject's rating of symptoms, the examiner assesses the clinical signs required for the Villalta and VCSS measures.
- Leg ulcers are assessed and measured by appropriately qualified personnel who are unaware of treatment arm allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet BOTH of these Criteria
- •Disabling (moderate-to-severe) PTS, defined by a) presence of chronic venous disease > or = 3 months duration in a leg with history of DVT, as determined by the site principal investigator or a physician co-investigator; and b) substantial limitation of daily activities or work capacity due to venous symptoms or an open venous ulcer, per the same investigator.
- •Ipsilateral iliac vein obstruction documented within 12 months prior to consent by either:
- •Occlusion or >50% or = 50% stenosis of the iliac vein on venogram, CT venogram, MR venogram, or intravascular ultrasound (IVUS) or
- •Air plethysmography showing deep venous obstruction of the ipsilateral leg (reduced venous outflow fraction), and ultrasound showing echogenic material in the ipsilateral iliac vein and non-phasic continuous Doppler flow in the ipsilateral common femoral vein (CFV) in the presence of normal phasic Doppler flow in the contralateral CFV.
排除标准
- •Subjects meeting any of these criteria will be excluded.
- •Age less than 18 years
- •Acute ipsilateral proximal DVT episode within the last 3 months, or acute contralateral DVT for which thrombolytic therapy is planned
- •Lack of suitable inflow into the ipsilateral common femoral vein per the treating physician
- •Previous stent placement in the infrarenal IVC or ipsilateral iliac or common femoral vein
- •Absence of PTS of at least moderate severity
- •Chronic arterial limb ischemia (ankle-brachial index < 0.5 within the previous 1 month) in the ipsilateral leg (if peripheral arterial disease is present or suspected, an ankle-brachial index should be obtained and documented)
- •Presence of open venous ulcer > 50 cm2 area, suspicion for active ulcer infection, or visualization of bone or tendon within the ulcer in the ipsilateral leg
- •Inability to tolerate endovascular procedure due to acute illness, or general health
- •Severe allergy to iodinated contrast refractory to steroid premedication
- •Known allergy to stent or catheter components
- •Hemoglobin < 8.0 g/dl, uncorrectable INR > 3.0, or platelet count < 75,000/ml
- •Severe renal impairment (on chronic dialysis or estimated GFR < 30 ml/min)
- •Disseminated intravascular coagulation or other major bleeding diathesis
- •Pregnancy (positive pregnancy test)
- •Life-expectancy < 6 months or chronically non-ambulatory for reasons other than PTS
- •Inability to provide informed consent or to comply with study assessments
- •Note - patients who initially meet an exclusion criterion can have eligibility re-evaluated on a subsequent occasion.
研究组 & 干预措施
Endovascular Therapy
Subjects randomized to EVT will receive the following:
- imaging-guided iliac vein stent placement;
- anticoagulant therapy for at least 6 months;
- oral aspirin 81 mg for at least 6 months; and
- optimal PTS therapy: medical, compression, lifestyle measures, and venous ulcer care
干预措施: Stents (Device)
No-Endovascular Therapy - Control
Optimal PTS therapy: medical, compression, lifestyle measures, and venous ulcer care
结局指标
主要结局
PTS Severity
时间窗: over 6 months follow-up
"Venous Clinical Severity Scale (VCSS) score, adjusted for baseline"
次要结局
- Venous quality of life(6 months)
- Gereric quality of life(6 months)
- Major bleeding(6 months)
- Recurrent venous thrombeombolism(6 months)
- Venous quality of life(12 months)
- Gereric quality of life(12 months)
- PTS severity (remote)(12 months)
- Venous quality of life(18 months)
- Gereric quality of life(18 months)
- PTS severity (remote)(18 months)
- Venous quality of life(24 months)
- Gereric quality of life(24 months)
- Estimated calf volume(6 months)
- Presence of open ulcer(6 months)
- PTS severity (secondary)(6 months)
- Major bleeding(24 months)
- Recurrent venous thrombeombolism(24 months)
- Death(6 months)
- Valvular reflux(6 months)
- Venous obstruction(6 months)
- PTS severity (remote)(24 months)
- Death Death(24 months)