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.
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.
Study Type
OBSERVATIONAL
Enrollment
50
removal of fresh soft emboli and thrombi from the vessels of the venous system
Vascular Care Connecticut
Darien, Connecticut, United States
The Vascular Care Group
Hyannis, Massachusetts, United States
The Vascular Care Group
Leominster, Massachusetts, United States
The Vascular Care Group
Plymouth, Massachusetts, United States
Primary Device Effectiveness
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
Time frame: Immediately after procedure
Change in revised Venous Clinical Severity Score (rVCSS)
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
Time frame: 30 days post index procedure
Change in Villalta Score
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.
Time frame: 30 Days Post Index Procedure
Change in EuroQol-5 Dimension (EQ-5D) Score
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.
Time frame: 30 Days Post Index Procedure
Primary Safety Endpoint
Serious adverse event related to the device, study procedure or secondary procedure to maintain or re-establish patency
Time frame: 12 months post index procedure
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The Vascular Care Group
Wellesley, Massachusetts, United States
The Vascular Care Group
Worcester, Massachusetts, United States
Total blood loss during procedure
The total blood loss for the duration of the procedure will be determined by the volume of blood in the collection bag, measured in milliliters, at the end of the procedure.
Time frame: immediately after index procedure
Age of Deep Vein occlusive disease
The Deep Vein occlusive disease will be categorized as one of the following depending on the age of the disease visualized during the procedure: Acute DVT, Acute DVT on chronic scar, chronic scar
Time frame: immediately after the procedure
Health Economics
Analysis of procedural reimbursement versus procedural cost of treatment
Time frame: 3 months post index procedure
Primary patency
Primary patency through 12 months of vein segments that were patent (\>50% lumen) at end of index procedure
Time frame: 12 months post index procedure
Assisted primary patency
required reintervention to maintain patency
Time frame: 12 months post index procedure
Change in revised Venous Clinical Severity Score (rVCSS)
Improvement of target leg 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
Time frame: 12 months post index procedure
Overall patient safety
Adverse event tracking
Time frame: 12 months post procedure
Change in Villalta Score
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.
Time frame: 12 months post index procedure
Change in EuroQol-5 Dimension (EQ-5D) Score
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.
Time frame: 12 months post index procedure