- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01994798
Rapid Exchange Devices Observational Registry. (RXRegistry)
22. april 2016 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Detaljeret 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
Undersøgelsestype
Observationel
Tilmelding (Forventet)
525
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Aalst, Belgien
- Onze-Lieve-Vrouwziekenhuis (OLV) Aalst
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Antwerp, Belgien
- GasthuisZusters Antwerpen (GZA) Ziekenhuizen
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Auvelais-Val de Sambre, Belgien
- Centre Hospitalier Régional (CHR) du Val de Sambre
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Hasselt, Belgien
- Jessa Ziekenhuis
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Liège, Belgien
- Centre Hospitalier Universitaire (CHU) Liège
-
-
-
-
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Burgos, Spanien
- Hospital Universitario de Burgos
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Girona, Spanien
- Hospital Universitari Dr. Josep Trueta de Girona
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Santander, Spanien
- Hospital Universitario Marques de Valdecilla
-
Valladolid, Spanien
- Hospital Clínico Universitario de Valladolid
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
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
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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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Christophe Martinez, Centre Hospitalier Universitaire (CHU) Liège
- Ledende efterforsker: Omar Andrés Navarro, Hospital Universitari Dr. Josep Trueta de Girona
- Ledende efterforsker: Josua Van den Berg, Ospedale regionale di Lugano
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2013
Primær færdiggørelse (Forventet)
1. september 2016
Studieafslutning (Forventet)
1. december 2016
Datoer for studieregistrering
Først indsendt
20. november 2013
Først indsendt, der opfyldte QC-kriterier
20. november 2013
Først opslået (Skøn)
26. november 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. april 2016
Sidst verificeret
1. april 2016
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- T122E2
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .