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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacomechanical thrombolysis plus anticoagulation | Experimental | This group of patients will receive Pharmacomechanical catheter-directed thrombolysis (PCDT) plus Anticoagulation. PCDT will be AngioJet along with alteplase. Anticoagulation will be heparin only |
|
| Anticoagulation | Active Comparator | This group of patients will receive standard anticoagulation only. Anticoagulation will be Heparin only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter directed thrombolysis plus anticoagulation | Combination Product | Patients will be randomized to pharmacomechanical catheter directed thrombolysis plus anticoagulation. PCDT will be AngioJet along with alteplase. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Post-thrombotic syndrome at 6 months. | Occurrence of post-thrombotic syndrome at 6 months measured by Villata score (Villalta score was 5 or higher). | 6 months |
| Post-thrombotic syndrome at 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ehab A Eltahawy, MD | University of Toledo Health Science Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toledo Medical Center | Toledo | Ohio | 43614 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19303507 | Background | Vedantham S. Valvular dysfunction and venous obstruction in the post-thrombotic syndrome. Thromb Res. 2009;123 Suppl 4:S62-5. doi: 10.1016/S0049-3848(09)70146-X. | |
| Background | DUTCH CAVA-trial: CAtheter Versus Anticoagulation Alone for Acute Primary (Ilio)Femoral DVT. Clinicaltrial.gov | ||
| 19224134 |
| Label | URL |
|---|---|
| DUTCH CAVA-trial: CAtheter Versus Anticoagulation Alone for Acute Primary (Ilio)Femoral DVT. (NL28394) | View source |
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| Anticoagulation | Drug | Patients will receive anticoagulation alone. Anticoagulation will be heparin only. |
|
Occurrence of post-thrombotic syndrome at 12 months measured by Villata score (Villalta score was 5 or higher).
| 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). | 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). | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 24 months |
| Health-Related Quality of Life AT 6 months | Health-Related Quality of Life measured by Venous Disease-Specific Quality of Life | 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. | 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. | 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. | 24 months |
| Health-Related Quality of Life at 6 months. | Health-Related Quality of Life measured by Generic Quality of Life at 6 months. | 6 months |
| Health-Related Quality of Life at 12 months. | Health-Related Quality of Life measured by Generic Quality of Life at 12 months | 12 months |
| Health-Related Quality of Life at 18 months. | Health-Related Quality of Life measured by Generic Quality of Life at 18 months. | 18 months |
| Health-Related Quality of Life at 24 months. | Health-Related Quality of Life measured by Generic Quality of Life at 24 months. | 24 months |
| Health-Related Quality of Life at 6 months. | Health-Related Quality of Life measured by Administration of QOL Measures at 6 months. | 6 months |
| Health-Related Quality of Life at 12 months. | Health-Related Quality of Life measured by Administration of QOL Measures at 12 months. | 12 months |
| Health-Related Quality of Life at 18 months. | Health-Related Quality of Life measured by Administration of QOL Measures at 18 months. | 18 months |
| Health-Related Quality of Life at 24 months. | Health-Related Quality of Life measured by Administration of QOL Measures at 24 months. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 24 months |
| Result |
| Ashrani AA, Heit JA. Incidence and cost burden of post-thrombotic syndrome. J Thromb Thrombolysis. 2009 Nov;28(4):465-76. doi: 10.1007/s11239-009-0309-3. Epub 2009 Feb 18. |
| 19017588 | Result | Kahn SR, Shrier I, Julian JA, Ducruet T, Arsenault L, Miron MJ, Roussin A, Desmarais S, Joyal F, Kassis J, Solymoss S, Desjardins L, Lamping DL, Johri M, Ginsberg JS. Determinants and time course of the postthrombotic syndrome after acute deep venous thrombosis. Ann Intern Med. 2008 Nov 18;149(10):698-707. doi: 10.7326/0003-4819-149-10-200811180-00004. |
| 25246013 | Result | Kahn SR, Comerota AJ, Cushman M, Evans NS, Ginsberg JS, Goldenberg NA, Gupta DK, Prandoni P, Vedantham S, Walsh ME, Weitz JI; American Heart Association Council on Peripheral Vascular Disease, Council on Clinical Cardiology, and Council on Cardiovascular and Stroke Nursing. The postthrombotic syndrome: evidence-based prevention, diagnosis, and treatment strategies: a scientific statement from the American Heart Association. Circulation. 2014 Oct 28;130(18):1636-61. doi: 10.1161/CIR.0000000000000130. Epub 2014 Sep 22. No abstract available. |
| 22277690 | Result | Comerota AJ, Grewal N, Martinez JT, Chen JT, Disalle R, Andrews L, Sepanski D, Assi Z. Postthrombotic morbidity correlates with residual thrombus following catheter-directed thrombolysis for iliofemoral deep vein thrombosis. J Vasc Surg. 2012 Mar;55(3):768-73. doi: 10.1016/j.jvs.2011.10.032. Epub 2012 Jan 24. |
| 11028492 | Result | Schweizer J, Kirch W, Koch R, Elix H, Hellner G, Forkmann L, Graf A. Short- and long-term results after thrombolytic treatment of deep venous thrombosis. J Am Coll Cardiol. 2000 Oct;36(4):1336-43. doi: 10.1016/s0735-1097(00)00863-9. |
| 6367454 | Result | Goldhaber SZ, Buring JE, Lipnick RJ, Hennekens CH. Pooled analyses of randomized trials of streptokinase and heparin in phlebographically documented acute deep venous thrombosis. Am J Med. 1984 Mar;76(3):393-7. doi: 10.1016/0002-9343(84)90656-9. |
| 12217281 | Result | Elsharawy M, Elzayat E. Early results of thrombolysis vs anticoagulation in iliofemoral venous thrombosis. A randomised clinical trial. Eur J Vasc Endovasc Surg. 2002 Sep;24(3):209-14. doi: 10.1053/ejvs.2002.1665. |
| 25047081 | Result | Bashir R, Zack CJ, Zhao H, Comerota AJ, Bove AA. Comparative outcomes of catheter-directed thrombolysis plus anticoagulation vs anticoagulation alone to treat lower-extremity proximal deep vein thrombosis. JAMA Intern Med. 2014 Sep;174(9):1494-501. doi: 10.1001/jamainternmed.2014.3415. |
| 22172244 | Result | Enden T, Haig Y, Klow NE, Slagsvold CE, Sandvik L, Ghanima W, Hafsahl G, Holme PA, Holmen LO, Njaastad AM, Sandbaek G, Sandset PM; CaVenT Study Group. Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): a randomised controlled trial. Lancet. 2012 Jan 7;379(9810):31-8. doi: 10.1016/S0140-6736(11)61753-4. Epub 2011 Dec 13. |
| 26853645 | Result | Haig Y, Enden T, Grotta O, Klow NE, Slagsvold CE, Ghanima W, Sandvik L, Hafsahl G, Holme PA, Holmen LO, Njaaastad AM, Sandbaek G, Sandset PM; CaVenT Study Group. Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial. Lancet Haematol. 2016 Feb;3(2):e64-71. doi: 10.1016/S2352-3026(15)00248-3. Epub 2016 Jan 6. |
| 29211671 | Result | Vedantham S, Goldhaber SZ, Julian JA, Kahn SR, Jaff MR, Cohen DJ, Magnuson E, Razavi MK, Comerota AJ, Gornik HL, Murphy TP, Lewis L, Duncan JR, Nieters P, Derfler MC, Filion M, Gu CS, Kee S, Schneider J, Saad N, Blinder M, Moll S, Sacks D, Lin J, Rundback J, Garcia M, Razdan R, VanderWoude E, Marques V, Kearon C; ATTRACT Trial Investigators. Pharmacomechanical Catheter-Directed Thrombolysis for Deep-Vein Thrombosis. N Engl J Med. 2017 Dec 7;377(23):2240-2252. doi: 10.1056/NEJMoa1615066. |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D054070 | Postthrombotic Syndrome |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014689 | Venous Insufficiency |
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