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Rapid Exchange Devices Observational Registry. (RXRegistry)

22. april 2016 oppdatert av: Terumo Europe N.V.

Prospective, Non-randomized, Multicentre, Observational Registry to Assess Clinically Relevant Benefit of Performing the Whole PTA Procedure Using the Rapid Exchange (RX) Devices.

This registry is designed to assess the clinically relevant benefits of balloon angioplasty and stenting in superficial femoral and popliteal artery, using rapid exchange technology.

Studieoversikt

Status

Ukjent

Forhold

Peripheral (Lowr Extremity) Arterial Disease.

Detaljert beskrivelse

This registry is designed to assess the clinically relevant benefits of balloon angioplasty and stenting in superficial femoral and popliteal artery, using rapid exchange technology

Studietype

Observasjonsmessig

Registrering (Forventet)

525

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Belgia
- - Aalst, Belgia
    - Onze-Lieve-Vrouwziekenhuis (OLV) Aalst
  - Antwerp, Belgia
    - GasthuisZusters Antwerpen (GZA) Ziekenhuizen
  - Auvelais-Val de Sambre, Belgia
    - Centre Hospitalier Régional (CHR) du Val de Sambre
  - Hasselt, Belgia
    - Jessa Ziekenhuis
  - Liège, Belgia
    - Centre Hospitalier Universitaire (CHU) Liège
Spania
- - Burgos, Spania
    - Hospital Universitario de Burgos
  - Girona, Spania
    - Hospital Universitari Dr. Josep Trueta de Girona
  - Santander, Spania
    - Hospital Universitario Marqués de Valdecilla
  - Valladolid, Spania
    - Hospital Clínico Universitario de Valladolid

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients with one lesion located in Superficial Femoral Artery(SFA) or popliteal artery planned to be treated as per hospital practice with plain old balloon angioplasty and nitinol stent using monorail (rapid exchange) delivery system.

Beskrivelse

Inclusion Criteria:

Patients with symptomatic one or two legs ischemia, requiring treatment of SFA or popliteal artery
Rutherford classification 2-5
Single lesion with recoiling/dissection/restenosis after balloon angioplasty or de novo lesions with stenosis or occlusion,
Target vessel reference diameter ≥4mm and ≤7mm (by visual estimate)
At least one patent (less than 50% stenosis) tibioperoneal run-off vessel confirmed by baseline angiography
Patient is suitable candidate for femoral-popliteal artery bypass surgery

Exclusion Criteria:

Female of child-bearing potential.
Previous bypass surgery
In stent restenosis as a target lesion
Scheduled staged procedure of multiple lesions within the ipsilateral iliac or popliteal arteries within 30 days after index procedure.
Co-existing aneurysmal disease of the abdominal aorta, iliac or popliteal arteries
Acute thrombophlebitis or deep venous thrombosis
Hemodynamic instability
Untreated inflow disease of the ipsilateral pelvic arteries (more than 50 percent stenosis or occlusion),
Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
Known intolerance to study medications, contrast agents or nitinol.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
Safety: composite of all-cause death, amputation, TVR, stroke or bleeding (BARC ≥ 3) up to 1 month Tidsramme: From start up to 30 Days post procedure.	From start up to 30 Days post procedure.
Total contrast media volume given during the procedure. Tidsramme: During procedure	During procedure

Sekundære resultatmål

Resultatmål	Tidsramme
Total duration of the procedure Tidsramme: During procedure	During procedure
Total fluoroscopy time Tidsramme: During procedure	During procedure
Total radiation dose given Tidsramme: During procedure	During procedure
Technical success defined as a successful access and balloon angioplasty followed by stent placement with achieved recanalization determined by less than 30% residual stenosis by angiography at the baseline procedure. Tidsramme: Pre- and post-procedure	Pre- and post-procedure
Clinical success defined as technically successful procedure without the events considered in safety composite endpoint (all-cause death, amputation, TVR, stroke or bleeding (BARC ≥ 3) up to 1 month. Tidsramme: During procedure	During procedure
Total acute complication rate defined as any device- or procedure- related complication up to 1 month post procedure. Tidsramme: Up to 30 Days post procedure	Up to 30 Days post procedure
Total acute device related complication rate defined as any device complication up to 1 month post procedure. Tidsramme: Up to 30 Days post procedure	Up to 30 Days post procedure
Ankle-Brachial Index (ABI) improvement at 30 days. Tidsramme: 30 Days post procedure	30 Days post procedure
Improvement of the Rutherford index at 30 days. Tidsramme: 30Days post procedure	30Days post procedure
Walking distance at 30 days compared with walking distance before procedure. Tidsramme: 30 Days post procedure	30 Days post procedure
Bleeding complication as per BARC definitions. Tidsramme: Up to 30 days post procedure	Up to 30 days post procedure

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Terumo Europe N.V.

Etterforskere

Hovedetterforsker: Christophe Martinez, Centre Hospitalier Universitaire (CHU) Liège
Hovedetterforsker: Omar Andrés Navarro, Hospital Universitari Dr. Josep Trueta de Girona
Hovedetterforsker: Josua Van den Berg, Ospedale Regionale di Lugano

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2013

Primær fullføring (Forventet)

1. september 2016

Studiet fullført (Forventet)

1. desember 2016

Datoer for studieregistrering

Først innsendt

20. november 2013

Først innsendt som oppfylte QC-kriteriene