Last reviewed · How we verify
NCT05827120: LEVANTE
Endovascular Therapy in Patients With Acute Deep Vein Thrombosis
trial testing Mechanical / pharmacomechanical thrombectomy plus local catheter directed thrombolysis in Acute Deep Venous Thrombosis in 110 participants. Completed in 24 February 2023.
24 February 2023
Quick facts
| Lead sponsor | National Institute of Cardiovascular Diseases, Slovakia |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 110 |
| Start date | 23 March 2021 |
| Primary completion | 24 February 2023 |
| Estimated completion | 24 February 2023 |
| Sites | 3 locations across Slovakia |
Drugs / interventions tested
- Mechanical / pharmacomechanical thrombectomy plus local catheter directed thrombolysis
- Local catheter directed thrombolysis alone
Conditions studied
- Acute Deep Venous Thrombosis — all drugs for Acute Deep Venous Thrombosis →
Sponsor
National Institute of Cardiovascular Diseases, Slovakia
Who can join
18 and older, any sex, with Acute Deep Venous Thrombosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Despite optimal anticoagulation therapy of patients with proximal deep vein thrombosis (DVT), there is still high number of patients suffering from post-thrombotic syndrome (PTS) due to the chronic venous occlusion, suboptimal collateralization, and venous valvular dysfunction. Last two decades endovascular catheter-based treatment modalities have been tested and used in an attempt to reduce incidence and symptoms of PTS in selected patients. Especially, patients with extensive iliofemoral DVT have an increased risk of PTS. In an effort to accelerate thrombus dissolution or thrombus extraction, the endovascular removal of acute venous thrombus has been introduced as therapeutic option in patients with extensive iliofemoral DVT. Randomized trials of catheter-based strategies for thrombus removal have documented improved vein patency, preserved valves function, and reduced post-thrombotic syndrome. The aim of our study is to evaluate the safety and efficacy of different types of endovascular methods of treatment followed by anticoagulation therapy in patients with acute extensive DVT. Retrospective multicentre analysis of app 100 patients scheduled for endovascular treatment of extensive DVT. The results of mechanical/pharmacomechanical thrombectomy followed by local catheter directed thrombolysis (CDT), will be compared with CDT alone, or with ultrasound-accelerated thrombolysis. The 24-month incidence of PTS assessed by Villalta scoring system, major bleeding complications, the rate of venous recanalization, recurrence of DVT, and other end-points will be evaluated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05827120
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other National Institute of Cardiovascular Diseases, Slovakia trials
Trials by the same sponsor.
- NCT04930302 — Optimizing the Pharmacotherapy of Vascular Surgery Patients at Hospital Admission, at Discharge and at Post-discharge Ch · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05827120 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Cardiovascular Diseases, Slovakia
- Last refreshed: 25 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05827120.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing