Phase
Condition
Thrombosis
Claudication
Venous Thromboembolism
Treatment
Thrombectomy
Clinical Study ID
Ages 18-89 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or Non-Pregnant Female, age 18 to 89.
For females of reproductive potential: negative pregnancy test ≤ 7 days before theprocedure, use of highly effective contraception (abstinence is acceptable) for 12months 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) spanningat least one of the following:
the iliac and/or common femoral vein. Extension into the femoral vein and/orprofunda vein is allowed. OR
the entire popliteal vein (above and below knee). Extension into the femoralvein and/or tibial veins is allowed.
People who have scheduled or will be scheduled for treatment with the QuickClearMechanical Thrombectomy system
Symptomatic DVT defined as meeting at least one of the following clinicalindicators:
rVCSS Pain Score ≥2
New edema of calf or thigh (CEAP ≥3)
Exclusion
Exclusion Criteria:
Non-ambulatory status prior to DVT occurrence.
Inability to lie in supine or prone under local anesthesia with moderate sedationfor procedure.
In the contralateral (non-study) leg: symptomatic DVT that, in the operatingphysician's opinion, will require treatment in the following 30 days.
Critical limb ischemia with ulcer, gangrene, or rest pain (i.e., above symptoms orfindings and ankle-brachial index <0.5, absolute ankle pressure <50 mm Hg orabsolute toe pressure <30 mmHg).
Pulmonary embolism (PE) defined as either massive (systolic blood pressure < 90 mmHg and/or patient on IV vasoactive medication to support blood pressure), orintermediate high-risk PE, as defined by the European Society Guideline onmanagement of PE. Low-risk PE and/or intermediate low-risk PE can be enrolled.
Inability to tolerate contemporary venous intervention procedure due to severedyspnea or acute systemic illness.
Allergy, hypersensitivity, or thrombocytopenia from heparin, iodinated contrast,except for mild-moderate contrast allergies for which steroid pre-medication can beused.
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) orsevere renal impairment in non-diabetic patients (eGFR< 30 ml/min).
Active bleeding, recent (< 3 mo) GI bleeding, severe liver dysfunction, bleedingdiathesis.
Recent (< 3 mo) internal eye surgery or hemorrhagic retinopathy; recent (<10 days)major surgery, cataract surgery, trauma, cardiopulmonary resuscitation, or otherinvasive procedure; or obstetrical delivery < 72 hours prior to procedure.
History of hemorrhagic stroke or intracranial/intraspinal bleed, tumor, vascularmalformation, aneurysm.
Active cancer with a life expectancy of < 1 year.
Severe hypertension on repeated readings (systolic blood pressure > 180 mm Hg ordiastolic blood pressure >105 mmHg). This can be treated, and blood pressure must bestable 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 thecommon iliac vein confluence.
Inability to obtain venous access.
Contraindication to Enoxaparin (e.g., Severe chronic kidney injury, allergicreaction, HIT)
Study Design
Study Description
Connect with a study center
Vascular Care Connecticut
Darien, Connecticut 06820
United StatesActive - Recruiting
The Vascular Care Group
Hyannis, Massachusetts 02601
United StatesActive - Recruiting
The Vascular Care Group
Leominster, Massachusetts 01453
United StatesSite Not Available
The Vascular Care Group
Plymouth, Massachusetts 02360
United StatesActive - Recruiting
The Vascular Care Group
Wellesley, Massachusetts 02482
United StatesActive - Recruiting
The Vascular Care Group
Worcester, Massachusetts 01605
United StatesActive - Recruiting
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