Clinical Safety, Feasibility, and Economic Viability of Performing Percutaneous Deep Vein Thrombectomy With the QuickClear Thrombectomy System in an Office Interventional Suite for Acute Lower Extremity Deep Vein Thrombosis (DVT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Change in Villalta Score
研究概览
简要总结
A post-market study of the QuickClear Mechanical Thrombectomy system used for the removal of acute Deep Vein Thrombosis (DVT) from the deep veins of legs in the setting of an office interventional suite.
详细描述
The QuickClear Mechanical Thrombectomy system will be used in accordance with the Instruction for Use (IFU) to remove acute, symptomatic occlusive common femoral, external iliac or common iliac DVT or occlusive above and below knee popliteal DVT in an office based interventional suite. The intent of this post-market observational study is to further assess long-term safety and effectiveness of patients treated with the QuickClear Mechanical Thrombectomy system and to assess the feasibility of performing deep vein thrombectomy procedures in the office interventional suite.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Non-Pregnant Female, age 18 to
- •For females of reproductive potential: negative pregnancy test ≤ 7 days before the procedure, use of highly effective contraception (abstinence is acceptable) for 12 months after the study treatment.
- •Onset of acute DVT symptoms of 14 days or less in the target limb.
- •Ability to take oral medication and be willing to adhere to the prescribed anti- coagulant regiment.
- •Occlusive DVT (confirmed by either venous duplex ultrasound or CT venogram) spanning at least one of the following:
- •the iliac and/or common femoral vein. Extension into the femoral vein and/or profunda vein is allowed. OR
- •the entire popliteal vein (above and below knee). Extension into the femoral vein and/or tibial veins is allowed.
- •People who have scheduled or will be scheduled for treatment with the QuickClear Mechanical Thrombectomy system
- •Symptomatic DVT defined as meeting at least one of the following clinical indicators:
- •rVCSS Pain Score ≥2
- •New edema of calf or thigh (CEAP ≥3)
排除标准
- •Non-ambulatory status prior to DVT occurrence.
- •Inability to lie in supine or prone under local anesthesia with moderate sedation for procedure.
- •In the contralateral (non-study) leg: symptomatic DVT that, in the operating physician's opinion, will require treatment in the following 30 days.
- •Critical limb ischemia with ulcer, gangrene, or rest pain (i.e., above symptoms or findings and ankle-brachial index <0.5, absolute ankle pressure <50 mm Hg or absolute toe pressure <30 mmHg).
- •Pulmonary embolism (PE) defined as either massive (systolic blood pressure < 90 mm Hg and/or patient on IV vasoactive medication to support blood pressure), or intermediate high-risk PE, as defined by the European Society Guideline on management of PE. Low-risk PE and/or intermediate low-risk PE can be enrolled.
- •Inability to tolerate contemporary venous intervention procedure due to severe dyspnea or acute systemic illness.
- •Allergy, hypersensitivity, or thrombocytopenia from heparin, iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
- •History of, or active heparin-induced thrombocytopenia (HIT).
- •Hemoglobin ≤9.0 mg/dl, INR>1.6 before starting anticoagulation, or platelets < 100,000/ml. Moderate renal impairment in diabetic patients (eGFR <60 ml/min) or severe renal impairment in non-diabetic patients (eGFR< 30 ml/min).
- •Active bleeding, recent (< 3 mo) GI bleeding, severe liver dysfunction, bleeding diathesis.
- •Recent (< 3 mo) internal eye surgery or hemorrhagic retinopathy; recent (<10 days) major surgery, cataract surgery, trauma, cardiopulmonary resuscitation, or other invasive procedure; or obstetrical delivery < 72 hours prior to procedure.
- •History of hemorrhagic stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
- •Active cancer with a life expectancy of < 1 year.
- •Severe hypertension on repeated readings (systolic blood pressure > 180 mm Hg or diastolic blood pressure >105 mmHg). This can be treated, and blood pressure must be stable before venous access is obtained (systolic blood pressure < 150 mmHg, diastolic blood pressure < 100 mm Hg).
- •Pregnant or breastfeeding or plans to become pregnant in the next 12 months.
- •Thrombus of the inferior vena cava (IVC) extending at least one centimeter above the common iliac vein confluence.
- •Inability to obtain venous access.
- •Contraindication to Enoxaparin (e.g., Severe chronic kidney injury, allergic reaction, HIT)
结局指标
主要结局
Change in Villalta Score
时间窗: 30 Days Post Index Procedure
Improvement of the Villalta Score. Villalta scores categorize the severity of post-thrombotic syndrome (PTS). Higher score indicates increasing severity of PTS. A score of greater or equal to 5 indicates PTS. PTS severity: total score of 5 to 9, mild PTS; score of 10 to 14, moderate PTS; and score of greater or equal to 15 or venous ulcer present, sever PTS. A negative change is associated with improved outcome.
Primary Safety Endpoint
时间窗: 12 months post index procedure
Serious adverse event related to the device, study procedure or secondary procedure to maintain or re-establish patency
Primary Device Effectiveness
时间窗: Immediately after procedure
Extent of acute DVT removal overall and in each segment (Common Iliac Vein (CIV), External Iliac Vein (EIV), Common Femoral Vein (CFV), Profunda Femoris Vein (PFV), Femoral Vein (FV), Popliteal (POP) as measured by IVUS and Venography
Change in revised Venous Clinical Severity Score (rVCSS)
时间窗: 30 days post index procedure
Improvement of target leg revised Venous Clinical Severity Score (rVCSS) Scores range from 0= no disease to 30= severe disease. Change in the rVCSS score is calculated as the follow-up score minus the Baseline score . A negative change is associated with improved outcome
Change in EuroQol-5 Dimension (EQ-5D) Score
时间窗: 30 Days Post Index Procedure
Higher score indicates a better quality of life. The questionnaire contains five dimensions where scores rank from 1 (best) to 5 (worst) plus a visual analog scale (VAS) (0=worst health; 100= best health). A positive change is associated with improved outcome. Change in EQ-5D scores are calculated as the Follow-up minus the Baseline score.
次要结局
- Health Economics(3 months post index procedure)
- Assisted primary patency(12 months post index procedure)
- Total blood loss during procedure(immediately after index procedure)
- Age of Deep Vein occlusive disease(immediately after the procedure)
- Primary patency(12 months post index procedure)
- Change in revised Venous Clinical Severity Score (rVCSS)(12 months post index procedure)
- Change in EuroQol-5 Dimension (EQ-5D) Score(12 months post index procedure)
- Overall patient safety(12 months post procedure)
- Change in Villalta Score(12 months post index procedure)
研究者
Paul J. Gagne
President, Vascular Breakthroughs, LLC
Vascular Care CT, PLLC