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Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System (DIRECT II)

9 aprile 2021 aggiornato da: Svelte Medical Systems, Inc.

Direct Implantation of Rapamycin-Eluting Stents With Bio-Erodible Drug Carrier Technology Utilizing the Second Generation Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS)

A prospective, randomized, active-control, multi-center clinical trial comparing the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to that of the commercially available Resolute IntegrityTM Drug-Eluting Stent.

The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, never previously treated coronary artery lesions

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

159

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Belgio
      • Aalst, Belgio
        • OLV Ziekenhuis Aalst
      • Antwerpen, Belgio
        • Middelheim Ziekenhuis
      • Genk, Belgio
        • ZOL GENK
      • Liege, Belgio
        • Chu Liege
  • Cechia
      • Prague, Cechia
        • Vseobecna Fakultni Nemocnice Praha
  • Francia
      • Rouen, Francia
        • Clinique Saint-Hilaire
      • Toulouse, Francia
        • CHU de Toulouse
      • Toulouse, Francia
        • Clinique Pasteur
  • Germania
      • Hamburg, Germania
        • University Medical Center Hamburg-Eppendorf
      • Hamburg, Germania
        • Medizinisches Verzorgungszentrum Prof. Mathey, Prof. Schofer
  • Olanda
      • Amsterdam, Olanda
        • OLVG Amsterdam
      • Eindhoven, Olanda
        • Catharina Hospital Eindhoven
      • Rotterdam, Olanda
        • Maasstad Ziekenhuis
      • Rotterdam, Olanda
        • Erasmus MC
      • Utrecht, Olanda
        • University Medical Center Utrecht, Department of Cardiology
  • Svezia
      • Malmo, Svezia
        • Skane University Hospital
      • Stockholm, Svezia
        • Sodersjukhuset
  • Svizzera
      • Bern, Svizzera
        • Inselspital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

General Inclusion Criteria

  1. Patient is ≥18 years old;
  2. Patient is eligible for percutaneous coronary intervention (PCI);
  3. Patient is an acceptable candidate for emergent coronary artery bypass graft (CABG) surgery;
  4. Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, or a positive functional study;
  5. Female subjects of childbearing potential must have a negative pregnancy test within 7-days before the trial procedure;
  6. Patient or subject's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Hospital Research Ethics Committee (HREC) of the respective investigational site; and
  7. Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed.

Angiographic Inclusion Criteria

  1. Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries;

  2. If a non-target lesion is treated, it must be treated first and only with commercially available PTCA balloons and/or stents. Post PCI of the non-target vessel, all of the following conditions must be met:

    1. Residual diameter stenosis < 30%;
    2. Absence of any angiographic complications;
    3. Absence of ischemic symptoms; and
    4. Absence of significant new arrhythmia or ECG monitoring changes suggestive of ischemia.
  3. Reference vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter by visual estimate;
  4. Target lesion < 20 mm in length by visual estimate (the intention is to cover the entire lesion with one stent of adequate length); and
  5. Target lesion stenosis ≥ 50% and < 100% by visual estimate.

Exclusion Criteria:

General Exclusion Criteria

  1. Patient is currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials;
  2. The patient requires a staged procedure of the target vessel within 6-months or a staged procedure of a non-target vessel within 30-days post-procedure;
  3. The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.);
  4. Any DES deployment anywhere in the target vessel within the past 9-months;
  5. Any BMS deployment anywhere in the target vessel within the past 6-months;
  6. Any previous stent placement within 10 mm (proximal or distal) of the target lesion;

  7. Myocardial infarction within 72-hours of the index procedure, with the exception of:

    1. Patients who have had a STEMI and PCI to the culprit lesion may be included if they have a suitable lesion in another vessel, and have been clinically and hemodynamically stable for 72-hours;
    2. Patients who have had a non-STEMI may be included if their troponin levels are within the laboratory normal range within 24-hours pre-procedure.
  8. Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial;
  9. Concurrent medical condition with a life expectancy of less than 12-months;
  10. Documented left ventricular ejection fraction (LVEF) ≤ 30%;
  11. Unstable angina pectoris from an extra-cardiac cause (Braunwald Class A I-III);
  12. Known allergies to the following: Acetylsalicylic acid (ASA), Clopidogrel bisulfate, Ticlopidine, Prasugrel, Rapamycin, Zotarolimus, PEAIII AcBz, Heparin/ Bivalirudin, or contrast agent (that cannot be adequately premedicated);
  13. Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3.000 cells/mm3 or hemoglobin < 100g/l;
  14. Acute or chronic renal dysfunction (serum creatinine > 170μmol/L);
  15. History of a stroke or transient ischemic attack (TIA) within the prior 6-months;
  16. Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6-months;
  17. History of bleeding diathesis or coagulopathy or will refuse blood transfusions; and
  18. Patients requiring ongoing anticoagulation with warfarin or dabigatran.

Angiographic Exclusion Criteria

  1. Total occlusion (TIMI 0 or 1);
  2. Target vessel has angiographic evidence of thrombus
  3. Target vessel is excessively tortuous or has heavy calcification;
  4. Significant (> 50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;
  5. Target lesion is located in or supplied by an arterial or venous bypass graft;
  6. Ostial target lesion (within 5.0 mm of vessel origin) or any location within the left main coronary artery;
  7. Target lesion involves a side branch > 2.0 mm in diameter; and
  8. Unprotected Left Main coronary disease (stenosis > 50%).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Svelte Drug-Eluting Coronary Stent
Coronary Stenting
Dispositivo: Coronary Stenting
Comparatore attivo: Medtronic Resolute Integrity Drug-Eluting Stent
Coronary Stenting
Dispositivo: Coronary Stenting

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Angiographic In-Stent Late Lumen Loss (LL)
Lasso di tempo: 6-months post-procedure
Defined as the measurements either within the stented segment or within 5 mm proximal and distal to the stent edges.
6-months post-procedure

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants Clinically-driven Target Lesion Revascularization (TLR)
Lasso di tempo: 1 year post-procedure
Clinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as unstable angina, that is, chest pain that increases in frequency, intensity or duration.
1 year post-procedure
Number of Participants Composite of Cardiac Death, MI Attributed to the Target Vessel and Clinically Driven Target Lesion Revascularization
Lasso di tempo: 1 year post-procedure
Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization
1 year post-procedure
Number of Participants Composite of All-cause Mortality, Any MI and Any Revascularization, Target Vessel Revascularization or Revascularization of Non Target Vessels
Lasso di tempo: 1 year post-procedure
Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of non target vessels
1 year post-procedure
Number of Participants Stent Thrombosis
Lasso di tempo: 1 year post-procedure
The sudden occlusion of a stented coronary artery due to thrombus formation.
1 year post-procedure
Number of Participants Acute Success Rates
Lasso di tempo: From index procedure to hospital discharge, an average of 24 hours
Direct Stenting Success, Lesion Success, Procedure Success and Device Failure
From index procedure to hospital discharge, an average of 24 hours
Number of Participants In-stent and In-segment Angiographic Binary Restenosis Rate
Lasso di tempo: 6-months post-procedure
The rate which restenosis occurs
6-months post-procedure
In-stent and In-segment Minimum Lumen Diameter
Lasso di tempo: 6-months post-procedure
Smallest diameter in the stent or segment area
6-months post-procedure
In-segment Late Lumen Loss
Lasso di tempo: 6-months post-procedure
Late lumen loss is the difference in millimeters between the diameter of a stented segment post-procedure compared with the follow-up angiogram
6-months post-procedure
Neointimal Hyperplasia as Measured by OCT
Lasso di tempo: 6-months post procedures
(% lumen volume)
6-months post procedures
Strut Coverage
Lasso di tempo: 6-months post procedure
(% of struts malapposed, protruding non-covered, protruding covered, non-protruding covered)
6-months post procedure
Number of Participants Target Vessel Failure
Lasso di tempo: 1 year post procedure
Composite endpoint of cardiac death, target vessel MI (Q or Non-Q wave), or clinically- driven target vessel revascularization (TVR) by percutaneous or surgical methods.
1 year post procedure

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Svelte Medical Systems, Inc.

Investigatori

  • Investigatore principale: Alexandre Abizaid, MD, PhD, Instituto Dante Pazzanese de Cardiologia
  • Investigatore principale: Stefan Verheye, MD, PhD, Antwerp Cardiovascular Institute

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2013

Completamento primario (Effettivo)

1 maggio 2014

Completamento dello studio (Effettivo)

31 maggio 2019

Date di iscrizione allo studio

Primo inviato

5 febbraio 2013

Primo inviato che soddisfa i criteri di controllo qualità

7 febbraio 2013

Primo Inserito (Stima)

11 febbraio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 aprile 2021

Ultimo verificato

1 aprile 2021

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IP-12-002

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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