- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02693158
The Direct III Post Market Study (Direct III)
Direct Implantation of Sirolimus-Eluting Stents With Bioresorbable Drug Carrier Technology Utilizing the Svelte Drug-Eluting Coronary Stent: The Direct III Post Market Study
Studieoversikt
Status
Forhold
Detaljert beskrivelse
In this post-market study, the population will include real-world subjects who are intended to be treated, with SLENDER IDS as standard therapy. Follow-up contacts post procedure will be made for clinical assessments at hospital discharge, 1, 6 and 12 months.
This study is designed as a prospective, multi-center, single-arm, observational all-comers clinical study to collect ongoing safety and efficacy of SLENDER IDS and to determine the feasibility of a direct stenting strategy in an all-comers population. A minimum of two hundred fifty (250) subjects will be treated at up to 20 sites in Europe.
Review of safety data and risks to subjects will be monitored by an independent Clinical Events Committee (CEC) at pre-specified enrollment milestones.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Amersfoort, Nederland
- Meander Medical Center
-
Amsterdam, Nederland, 1091 AC
- OLVG
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Blaricum, Nederland, 1261AN
- Tergooi Hospital
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Breda, Nederland, 4819 EV
- Amphia Ziekenhuis
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Dordrecht, Nederland, 3300 AK
- Albert Schweitzer Hospital
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Nieuwegein, Nederland, 3430 EM
- St Antonius Hospital
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The Hague, Nederland, 2545 AA
- Hagaziekenhuis
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Utrecht, Nederland
- University Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Subject is ≥ 18 years old;
- Subject has symptomatic heart disease due to coronary artery lesions of length < 28 mm and a reference vessel diameter 2.5 - 4.0 mm.
- Subject is intended to be treated with PCI and implantation of SLENDER IDS as part of his/her standard treatment
- Subject or subject's legal representative understands the study requirements and the treatment procedures and provides written informed consent before any study specific tests or procedures are performed.
Exclusion Criteria:
- Subject is unable to receive anti-platelet and/or anti-coagulant therapy;
- Subject is allergic to sirolimus, PEA III Ac Bz, cobalt, chromium, nickel or tungsten;
- The subject is judged to have lesions preventing complete inflation of an angioplasty balloon or proper placement of a coronary stent, including chronic total occlusions.
- Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential, based on the standard of care for the cath lab);
- Subject is participating in another investigational drug or device clinical trial that the investigator feels would interfere with the subject's participation in this study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Target Lesion Failure (TLF)
Tidsramme: 12 months
|
Cardiac Death, Target Vessel Myocardial Infarction (TVMI) (Q wave and non-Q wave) or clinically driven Target Lesion Revascularization (TLR) by percutaneous or surgical methods.
|
12 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Target Vessel Failure (TVF)
Tidsramme: Discharge, 1, 6 and 12 months
|
composite endpoint of Cardiac Death, Target Vessel MI, or clinically-driven Target Vessel Revascularization (TVR) by percutaneous or surgical methods.
|
Discharge, 1, 6 and 12 months
|
Major Adverse Cardiac Event (MACE)
Tidsramme: Discharge, 1, 6 and 12 months
|
defined as a composite of all deaths, Target Vessel MI (Q wave and non-Q wave), emergent coronary artery bypass grafting surgery (CABG), or clinically-driven repeat Target Lesion Revascularization (TLR) by percutaneous or surgical methods.
|
Discharge, 1, 6 and 12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Dennis Donohoe, MD, Svelte Medical
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IP-15-002
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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