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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Patients will be randomized to pharmacomechanical catheter directed thrombolysis plus anticoagulation. PCDT will be AngioJet along with alteplase.
Patients will receive anticoagulation alone. Anticoagulation will be heparin only.
University of Toledo Medical Center
Toledo, Ohio, United States
Post-thrombotic syndrome at any time between 6-month and 24-month.
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.
Time frame: 6-24 months
Post-thrombotic syndrome at 6 months.
Occurrence of post-thrombotic syndrome at 6 months measured by Villata score (Villalta score was 5 or higher).
Time frame: 6 months
Post-thrombotic syndrome at 12 months.
Occurrence of post-thrombotic syndrome at 12 months measured by Villata score (Villalta score was 5 or higher).
Time frame: 12 months
Post-thrombotic syndrome at 18 months.
Occurrence of post-thrombotic syndrome at 18 months measured by Villata score (Villalta score was 5 or higher).
Time frame: 18 months
Post-thrombotic syndrome at 24 months.
Occurrence of post-thrombotic syndrome at 24 months measured by Villata score (Villalta score was 5 or higher).
Time frame: 24 months
Villalta scale at 6 months
The severity of the post-thrombotic syndrome to be evaluated at 6 months with the use of the Villalta scale
Time frame: 6 months
Villalta scale at 12 months
The severity of the post-thrombotic syndrome to be evaluated at 12 months with the use of the Villalta scale.
Time frame: 12 months
Villalta scale at 18 months
The severity of the post-thrombotic syndrome to be evaluated at 18 months with the use of the Villalta scale.
Time frame: 18 months
Villalta scale at 24 months
The severity of the post-thrombotic syndrome to be evaluated at 18 months with the use of the Villalta scale.
Time frame: 24 months
Venous Clinical Severity Score at 6 months
The severity of the post-thrombotic syndrome to be evaluated at 6 months with the use of the Venous Clinical Severity Score.
Time frame: 6 months
Venous Clinical Severity Score at 12 months
The severity of the post-thrombotic syndrome to be evaluated at 12 months with the use of the Venous Clinical Severity Score.
Time frame: 12 months
Venous Clinical Severity Score at 18 months
The severity of the post-thrombotic syndrome to be evaluated at 18 months with the use of the Venous Clinical Severity Score.
Time frame: 18 months
Venous Clinical Severity Score at 24 months
The severity of the post-thrombotic syndrome to be evaluated at 24 months with the use of the Venous Clinical Severity Score.
Time frame: 24 months
Health-Related Quality of Life AT 6 months
Health-Related Quality of Life measured by Venous Disease-Specific Quality of Life
Time frame: 6 months
Health-Related Quality of Life at 12 months.
Health-Related Quality of Life measured by Venous Disease-Specific Quality of Life at 12 months.
Time frame: 12 months
Health-Related Quality of Life at 18 months.
Health-Related Quality of Life measured by Venous Disease-Specific Quality of Life at 18 months.
Time frame: 18 months
Health-Related Quality of Life at 24 months.
Health-Related Quality of Life measured by Venous Disease-Specific Quality of Life at 24 months.
Time frame: 24 months
Health-Related Quality of Life at 6 months.
Health-Related Quality of Life measured by Generic Quality of Life at 6 months.
Time frame: 6 months
Health-Related Quality of Life at 12 months.
Health-Related Quality of Life measured by Generic Quality of Life at 12 months
Time frame: 12 months
Health-Related Quality of Life at 18 months.
Health-Related Quality of Life measured by Generic Quality of Life at 18 months.
Time frame: 18 months
Health-Related Quality of Life at 24 months.
Health-Related Quality of Life measured by Generic Quality of Life at 24 months.
Time frame: 24 months
Health-Related Quality of Life at 6 months.
Health-Related Quality of Life measured by Administration of QOL Measures at 6 months.
Time frame: 6 months
Health-Related Quality of Life at 12 months.
Health-Related Quality of Life measured by Administration of QOL Measures at 12 months.
Time frame: 12 months
Health-Related Quality of Life at 18 months.
Health-Related Quality of Life measured by Administration of QOL Measures at 18 months.
Time frame: 18 months
Health-Related Quality of Life at 24 months.
Health-Related Quality of Life measured by Administration of QOL Measures at 24 months.
Time frame: 24 months
Treatment Failures that are Not PTS.
Treatment Failures that are Not PTS (defined as one or more of the following during the 24 months post randomization: 1) the patient underwent an unplanned endovascular or surgical intervention for the treatment of severe symptomatic venous disease in the index leg within the first 24 months after randomization (2) the subject underwent an amputation in the index leg anytime within 24 months after randomization; or (3) the subject developed venous gangrene in the index leg within the first 24 months after randomization.
Time frame: 6-24 months
Severity of presenting DVT Symptoms at 6 months
Severity of presenting DVT Symptoms (Leg pain severity measured by pain scale) at 6 months
Time frame: 6 months
Severity of presenting DVT Symptoms at 12 months
Severity of presenting DVT Symptoms (Leg pain severity measured by pain scale) at 12 months
Time frame: 12 months
Severity of presenting DVT Symptoms at 18 months
Severity of presenting DVT Symptoms (Leg pain severity measured by pain scale) at 18 months
Time frame: 18 months
Severity of presenting DVT Symptoms at 24 months
Severity of presenting DVT Symptoms (Leg pain severity measured by pain scale) at 24 months
Time frame: 24 months
Severity of presenting DVT Symptoms at 6 months
Severity of presenting DVT Symptoms (Leg swelling measured by measuring calf swelling) at 6 months
Time frame: 6 months
Severity of presenting DVT Symptoms at 12 months
Severity of presenting DVT Symptoms (Leg swelling measured by measuring calf swelling) at 12 months
Time frame: 12 months
Severity of presenting DVT Symptoms at 18 months
Severity of presenting DVT Symptoms (Leg swelling measured by measuring calf swelling) at 18 months
Time frame: 18 months
Severity of presenting DVT Symptoms at 24 months
Severity of presenting DVT Symptoms (Leg swelling measured by measuring calf swelling) at 24 months
Time frame: 24 months
Degree of Resolution of Thrombus with PCDT at 6 months.
Degree of Resolution of Thrombus with PCDT (Assessed by two sets of venograms in PCDT arm, one baseline venogram of the proximal veins (popliteal vein through infrarenal IVC) obtained after initial catheter insertion into the venous system before PCDT; and one the final venogram of the proximal veins obtained after PCDT and any adjunctive procedures, before sheath removal. Marder score will be used to quantify clot burden. Marder score range 0-24, with 0 representing no thrombus and 24 representing complete thrombosis). The degree of thrombus elimination (% change in pre-PCDT and post-PCDT Marder score) will be calculated.
Time frame: 6 months
Degree of Resolution of Thrombus with PCDT at 12 months.
Degree of Resolution of Thrombus with PCDT (Assessed by two sets of venograms in PCDT arm, one baseline venogram of the proximal veins (popliteal vein through infrarenal IVC) obtained after initial catheter insertion into the venous system before PCDT; and one the final venogram of the proximal veins obtained after PCDT and any adjunctive procedures, before sheath removal. Marder score will be used to quantify clot burden. Marder score range 0-24, with 0 representing no thrombus and 24 representing complete thrombosis). The degree of thrombus elimination (% change in pre-PCDT and post-PCDT Marder score) will be calculated.
Time frame: 12 months
Degree of Resolution of Thrombus with PCDT at 18 months.
Degree of Resolution of Thrombus with PCDT (Assessed by two sets of venograms in PCDT arm, one baseline venogram of the proximal veins (popliteal vein through infrarenal IVC) obtained after initial catheter insertion into the venous system before PCDT; and one the final venogram of the proximal veins obtained after PCDT and any adjunctive procedures, before sheath removal. Marder score will be used to quantify clot burden. Marder score range 0-24, with 0 representing no thrombus and 24 representing complete thrombosis). The degree of thrombus elimination (% change in pre-PCDT and post-PCDT Marder score) will be calculated.
Time frame: 18 months
Degree of Resolution of Thrombus with PCDT at 24 months.
Degree of Resolution of Thrombus with PCDT (Assessed by two sets of venograms in PCDT arm, one baseline venogram of the proximal veins (popliteal vein through infrarenal IVC) obtained after initial catheter insertion into the venous system before PCDT; and one the final venogram of the proximal veins obtained after PCDT and any adjunctive procedures, before sheath removal. Marder score will be used to quantify clot burden. Marder score range 0-24, with 0 representing no thrombus and 24 representing complete thrombosis). The degree of thrombus elimination (% change in pre-PCDT and post-PCDT Marder score) will be calculated.
Time frame: 24 months
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