Deep Venous ThrombosisPhase 4NCT04411316

Catheter-directed Thrombolysis Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis

A Phase 4 study testing Catheter directed thrombolysis plus anticoagulation and Anticoagulation in people with Deep Venous Thrombosis and Post Thrombotic Syndrome, run by University of Toledo Health Science Campus at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Deep Venous Thrombosis, Post Thrombotic Syndrome
What is being tested?: Catheter directed thrombolysis plus anticoagulation and Anticoagulation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 19 Dec 2019to 19 Dec 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age>18 and younger than 75
Symptomatic, proximal deep-vein thrombosis involving the Iliofemoral vein from 12/01/2019 to 12/01/2022

Who cannot join

Age less than 18 years or greater than 75 years.
Symptom duration > 14 days for the DVT episode in the index leg (i.e. non-acute DVT).
In the index leg: established PTS, or previous symptomatic DVT within the last 2 years.
In the contralateral (non-index) leg: symptomatic acute DVT a) involving the popliteal and/or tibial veins; or b) for which thrombolysis is planned as part of initial therapy.
Limb-threatening circulatory compromise.
PE with hemodynamic compromise (i.e. hypotension).

Show all 20Show fewer

Inability to tolerate PCDT procedure due to severe dyspnea or acute systemic illness.
Allergy, hypersensitivity, or thrombocytopenia from heparin, rt-PA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
Hemoglobin < 9.0 mg/dl, INR > 1.6 before warfarin was started, or platelets < 100,000 /ml.
Moderate renal impairment in diabetic patients (estimated GFR < 60 ml/min) or severe renal impairment in non-diabetic patients (estimated GFR < 30 ml/min).
Active bleeding, recent (< 3 months) GI bleeding, severe liver dysfunction, bleeding diathesis.
Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy; recent (< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.
History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, aneurysm.
Active cancer (metastatic, progressive, or treated within the last 6 months). Exception: patients with non-melanoma primary skin cancers are eligible to participate in the study.
Severe hypertension on repeated readings (systolic > 180mmHg or diastolic > 105 mmHg).
Pregnant (positive pregnancy test, women of childbearing potential must be tested).
Recently (< 2 years or chronic non-ambulatory status.
Use of a thienopryridine antiplatelet drug (except clopidogrel) in the last 5 days.
Life expectancy < 2 years or chronic non-ambulatory status.
Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance).

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Toledo Medical Center
Toledo, Ohio, 43614

Other trials in United States

About this study

Official title: Pharmacomechanical Catheter-directed Thrombolysis (PCDT) Plus Anticoagulation Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis:

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.

Read the detailed description

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.

Conditions: Deep Venous Thrombosis, Post Thrombotic Syndrome
Being tested: Catheter directed thrombolysis plus anticoagulation, Anticoagulation
Medical subject headings: Venous Thrombosis, Postthrombotic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Catheter directed thrombolysis plus anticoagulationCombination product
Also called Pharmacomechanical thrombolysis
Patients will be randomized to pharmacomechanical catheter directed thrombolysis plus anticoagulation.
PCDT will be AngioJet along with alteplase.
AnticoagulationDrug
Patients will receive anticoagulation alone. Anticoagulation will be heparin only.

Study groups in NCT04411316
Study group	Role	What they receive
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 Receives: Combination Product: Catheter directed thrombolysis plus anticoagulation
Anticoagulation	Active comparator	This group of patients will receive standard anticoagulation only. Anticoagulation will be Heparin only Receives: Drug: Anticoagulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6-24 months

Secondary outcomes (37)

Post-thrombotic syndrome at 6 months.
Occurrence of post-thrombotic syndrome at 6 months measured by Villata score (Villalta score was 5 or higher).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Health-Related Quality of Life AT 6 months
Health-Related Quality of Life measured by Venous Disease-Specific Quality of Life
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Health-Related Quality of Life at 6 months.
Health-Related Quality of Life measured by Generic Quality of Life at 6 months.
Measured: 6 months
Health-Related Quality of Life at 12 months.
Health-Related Quality of Life measured by Generic Quality of Life at 12 months
Measured: 12 months
Health-Related Quality of Life at 18 months.
Health-Related Quality of Life measured by Generic Quality of Life at 18 months.
Measured: 18 months
Health-Related Quality of Life at 24 months.
Health-Related Quality of Life measured by Generic Quality of Life at 24 months.
Measured: 24 months
Health-Related Quality of Life at 6 months.
Health-Related Quality of Life measured by Administration of QOL Measures at 6 months.
Measured: 6 months
Health-Related Quality of Life at 12 months.
Health-Related Quality of Life measured by Administration of QOL Measures at 12 months.
Measured: 12 months
Health-Related Quality of Life at 18 months.
Health-Related Quality of Life measured by Administration of QOL Measures at 18 months.
Measured: 18 months
Health-Related Quality of Life at 24 months.
Health-Related Quality of Life measured by Administration of QOL Measures at 24 months.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Dec 201919 Dec 2022

First posted2 Jun 2020
Study start19 Dec 2019
Primary completion19 Dec 2022 (estimated)
Study completion19 Dec 2022 (estimated)

Why it stopped: Zero Patients met criteria

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04411316
Sponsor's protocol ID: 300439
Status last verified: Sep 2021
First submitted: 7 May 2020
Last updated: 9 Sep 2021
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 19303507
DUTCH CAVA-trial: CAtheter Versus Anticoagulation Alone for Acute Primary (Ilio)Femoral DVT. Clinicaltrial.gov
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.
PubMed 19224134
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.
PubMed 19017588
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.
PubMed 25246013
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.
PubMed 22277690
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.
PubMed 11028492
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.
PubMed 6367454
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.
PubMed 12217281
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.
PubMed 25047081
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.
PubMed 22172244
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.
PubMed 26853645
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.
PubMed 29211671

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacomechanical Catheter-directed Thrombolysis (PCDT) Plus Anticoagulation Compared to Anticoagulation Alone for Acute Primary Iliofemoral Deep Venous Thrombosis:
ClinicalTrials.gov ID: NCT04411316
Acronym / sponsor ID: 300439
Conditions: Deep Venous Thrombosis, Post Thrombotic Syndrome
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Zero Patients met criteria
Enrolment: 0 participants (actual)
Lead sponsor: University of Toledo Health Science CampusUniversity, hospital or other
Study start: 19 Dec 2019 (actual)
Primary completion: 19 Dec 2022 (estimated)
Study completion: 19 Dec 2022 (estimated)
First posted: 2 Jun 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pharmacomechanical thrombolysis plus anticoagulation	Experimental	Combination Product: Catheter directed thrombolysis plus anticoagulationThis 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	Drug: AnticoagulationThis group of patients will receive standard anticoagulation only. Anticoagulation will be Heparin only

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Age>18 and younger than 75
Symptomatic, proximal deep-vein thrombosis involving the Iliofemoral vein from 12/01/2019 to 12/01/2022

Key exclusion criteria (20 listed)

Age less than 18 years or greater than 75 years.
Symptom duration > 14 days for the DVT episode in the index leg (i.e. non-acute DVT).
In the index leg: established PTS, or previous symptomatic DVT within the last 2 years.
In the contralateral (non-index) leg: symptomatic acute DVT a) involving the popliteal and/or tibial veins; or b) for which thrombolysis is planned as part of initial therapy.
Limb-threatening circulatory compromise.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Catheter directed thrombolysis plus anticoagulationAlso: Pharmacomechanical thrombolysisPatients will be randomized to pharmacomechanical catheter directed thrombolysis plus anticoagulation. PCDT will be AngioJet along with alteplase.	Combination product	Pharmacomechanical thrombolysis plus anticoagulation
AnticoagulationPatients will receive anticoagulation alone. Anticoagulation will be heparin only.	Drug	Anticoagulation

Primary outcome

Post-thrombotic syndrome at any time between 6-month and 24-month.
Time frame: 6-24 months
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.

37 secondary outcomes

Post-thrombotic syndrome at 6 months.
Time frame: 6 months
Post-thrombotic syndrome at 12 months.
Time frame: 12 months
Post-thrombotic syndrome at 18 months.
Time frame: 18 months
Post-thrombotic syndrome at 24 months.
Time frame: 24 months
Villalta scale at 6 months
Time frame: 6 months
Villalta scale at 12 months
Time frame: 12 months
Villalta scale at 18 months
Time frame: 18 months
Villalta scale at 24 months
Time frame: 24 months
Venous Clinical Severity Score at 6 months
Time frame: 6 months
Venous Clinical Severity Score at 12 months
Time frame: 12 months
Venous Clinical Severity Score at 18 months
Time frame: 18 months
Venous Clinical Severity Score at 24 months
Time frame: 24 months
Health-Related Quality of Life AT 6 months
Time frame: 6 months
Health-Related Quality of Life at 12 months.
Time frame: 12 months
Health-Related Quality of Life at 18 months.
Time frame: 18 months
Health-Related Quality of Life at 24 months.
Time frame: 24 months
Health-Related Quality of Life at 6 months.
Time frame: 6 months
Health-Related Quality of Life at 12 months.
Time frame: 12 months
Health-Related Quality of Life at 18 months.
Time frame: 18 months
Health-Related Quality of Life at 24 months.
Time frame: 24 months
Health-Related Quality of Life at 6 months.
Time frame: 6 months
Health-Related Quality of Life at 12 months.
Time frame: 12 months
Health-Related Quality of Life at 18 months.
Time frame: 18 months
Health-Related Quality of Life at 24 months.
Time frame: 24 months
Treatment Failures that are Not PTS.
Time frame: 6-24 months
Severity of presenting DVT Symptoms at 6 months
Time frame: 6 months
Severity of presenting DVT Symptoms at 12 months
Time frame: 12 months
Severity of presenting DVT Symptoms at 18 months
Time frame: 18 months
Severity of presenting DVT Symptoms at 24 months
Time frame: 24 months
Severity of presenting DVT Symptoms at 6 months
Time frame: 6 months
Severity of presenting DVT Symptoms at 12 months
Time frame: 12 months
Severity of presenting DVT Symptoms at 18 months
Time frame: 18 months
Severity of presenting DVT Symptoms at 24 months
Time frame: 24 months
Degree of Resolution of Thrombus with PCDT at 6 months.
Time frame: 6 months
Degree of Resolution of Thrombus with PCDT at 12 months.
Time frame: 12 months
Degree of Resolution of Thrombus with PCDT at 18 months.
Time frame: 18 months
Degree of Resolution of Thrombus with PCDT at 24 months.
Time frame: 24 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
Background: PubMed 19303507Vedantham 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.
BackgroundDUTCH CAVA-trial: CAtheter Versus Anticoagulation Alone for Acute Primary (Ilio)Femoral DVT. Clinicaltrial.gov
Results publication: PubMed 19224134Ashrani 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.
Results publication: PubMed 19017588Kahn 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.
Results publication: PubMed 25246013Kahn 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.
Results publication: PubMed 22277690Comerota 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.
Results publication: PubMed 11028492Schweizer 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.
Results publication: PubMed 6367454Goldhaber 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.
Results publication: PubMed 12217281Elsharawy 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.
Results publication: PubMed 25047081Bashir 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.
Results publication: PubMed 22172244Enden 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.
Results publication: PubMed 26853645Haig 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.
DUTCH CAVA-trial: CAtheter Versus Anticoagulation Alone for Acute Primary (Ilio)Femoral DVT. (NL28394)Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ehab A Eltahawy, MD principal investigator

University of Toledo Health Science Campus

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-thrombotic syndrome at any time between 6-month and 24-month. (time frame: 6-24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04411316, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.