- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02752802
DyeVert System RCT
Single Site Randomized Control Trial Evaluating the DyeVert System
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a prospective, randomized, parallel group, single center clinical evaluation of the DyeVert System. Subjects undergoing a diagnostic coronary angiogram procedure with a 5 French catheter are eligible to participate in this study. The treatment group will use the DyeVert System.
The trial will be conducted at one center, located in Germany. A sample size of 96 evaluable subjects will provide a sufficient number of samples to evaluate the primary objectives.
Randomization will occur following confirmation that the subject meets the inclusion/exclusion criteria and has signed an informed consent. Subjects that are anticipated to be a diagnostic only procedure, but end up being an ad-hoc PCI, can still remain enrolled in the trial. If a subject proceeds to a PCI, data will only be collected through the diagnostic portion of the case.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Lübeck, Tyskland, 23538
- University Hospital of Schleswig-Holstein
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- The subject is indicated for a diagnostic coronary angiogram procedure with a 5 French catheter only.
- The subject is ≥ 18 years of age
- The subject is willing and able to provide appropriate informed consent.
Exclusion Criteria:
- Subject is undergoing a STEMI procedure
- Subject has previously been diagnosed with anomalous coronary anatomy
- Subject has previously underwent coronary artery bypass grafting
- Subject has severe peripheral artery disease at access site
- Subject is having a staged PCI
- The subject is female and currently pregnant
- In the investigator's opinion, the subject is not considered to be a suitable candidate
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Treatment
The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.
|
Diagnostic angiographic procedure with the use of the DyeVert System.
|
Aktiv komparator: Control
The control group will include standard of care for diagnostic coronary angiograms.
|
Diagnostic angiographic procedure with the use of the DyeVert System.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.
Tidsram: All data will be collected on the day of the procedure, over an average of 12 hours.
|
DyeVert is intended to reduce the total amount of contrast media (CM) administered during procedures requiring the injection of contrast media.
Clinical evidence has demonstrated that CM can be toxic to the kidneys, leading to contrast induced nephropathy (CIN)
|
All data will be collected on the day of the procedure, over an average of 12 hours.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Assessment of the Quality of Angiographic Images Between Groups
Tidsram: AlAll data will be collected on the day of the procedure, over an average of 12 hours.
|
To assess the adequacy of the image quality.
The proportion of images in which contrast opacification is deemed sufficient to evaluate the desired anatomical structures adequately will be compared between the DyeVert and control groups.
|
AlAll data will be collected on the day of the procedure, over an average of 12 hours.
|
Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure.
Tidsram: All data will be collected on the day of the procedure, over an average of 12 hours.
|
To assess the incidence of Serious Adverse Device Effect for subjects treated with the DyeVert System during the procedure for treatment subjects only.
|
All data will be collected on the day of the procedure, over an average of 12 hours.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Steffen Desch, MD, University Hospital of Schleswig-Holstein, Lubeck
Publikationer och användbara länkar
Allmänna publikationer
- Lameire N, Kellum JA; KDIGO AKI Guideline Work Group. Contrast-induced acute kidney injury and renal support for acute kidney injury: a KDIGO summary (Part 2). Crit Care. 2013 Feb 4;17(1):205. doi: 10.1186/cc11455.
- Brown JR, Solomon RJ, Sarnak MJ, McCullough PA, Splaine ME, Davies L, Ross CS, Dauerman HL, Stender JL, Conley SM, Robb JF, Chaisson K, Boss R, Lambert P, Goldberg DJ, Lucier D, Fedele FA, Kellett MA, Horton S, Phillips WJ, Downs C, Wiseman A, MacKenzie TA, Malenka DJ; Northern New England Cardiovascular Disease Study Group. Reducing contrast-induced acute kidney injury using a regional multicenter quality improvement intervention. Circ Cardiovasc Qual Outcomes. 2014 Sep;7(5):693-700. doi: 10.1161/CIRCOUTCOMES.114.000903. Epub 2014 Jul 29.
- Gruberg L, Mintz GS, Mehran R, Gangas G, Lansky AJ, Kent KM, Pichard AD, Satler LF, Leon MB. The prognostic implications of further renal function deterioration within 48 h of interventional coronary procedures in patients with pre-existent chronic renal insufficiency. J Am Coll Cardiol. 2000 Nov 1;36(5):1542-8. doi: 10.1016/s0735-1097(00)00917-7.
- Klein LW, Sheldon MW, Brinker J, Mixon TA, Skelding K, Strunk AO, Tommaso CL, Weiner B, Bailey SR, Uretsky B, Kern M, Laskey W; Interventional Committee of the Society for Cardiovascular Angiography and Interventions. The use of radiographic contrast media during PCI: a focused review: a position statement of the Society of Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2009 Nov 1;74(5):728-46. doi: 10.1002/ccd.22113. No abstract available.
- Levy EM, Viscoli CM, Horwitz RI. The effect of acute renal failure on mortality. A cohort analysis. JAMA. 1996 May 15;275(19):1489-94.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- TP-6495
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Koronar angiografi
-
IRCCS Policlinico S. DonatoRekryteringAnomalous aortic origin of the coronary artery (AAOCA)Italien
-
Biotronik AGAvslutadde Novo Lesions in Native coronary arteriesNederländerna, Schweiz, Tyskland, Belgien
-
Osaka General Medical CenterAvslutadEmergent coronary procedurJapan
-
Claudia SpiesAvslutadOmskärelse, Meatotomy eller Distal Coronary Correction of HypospadiaTyskland
-
Tel-Aviv Sourasky Medical CenterAvslutadKonsekutiva ämnen som är lämpliga för en kranskärlssjukdom | Angioplastik av de Novo lesion(er) i Native Coronary | Artärer bör undersökas för behörighet. | Totalt antal 200 patienter som uppfyller urvalet | Kriterier och villig att underteckna det informerade samtycket | vara inskriven i provet.Israel
-
RenJi HospitalAvslutadST Segment Elevation Myokardinfarkt | Coronary Slow Flow FenomenKina
Kliniska prövningar på Diagnostic Coronary Angiogram
-
University of MichiganAvslutad
-
Ottawa Hospital Research InstituteThe Ottawa HospitalAvslutad
-
AUM Cardiovascular, Inc.AvslutadKranskärlssjukdomFörenta staterna
-
Emory UniversityNational Heart, Lung, and Blood Institute (NHLBI); Samsung Medical Center; Chonnam National University Hospital och andra samarbetspartnersAvslutadKranskärlssjukdomKorea, Republiken av, Förenta staterna
-
Philips Clinical & Medical Affairs GlobalAvslutadKranskärlssjukdomIsrael, Förenta staterna, Belgien, Spanien
-
Papworth Hospital NHS Foundation TrustCambridge University Hospitals NHS Foundation TrustHar inte rekryterat ännu
-
University of ValenciaInstituto de Salud Carlos IIIAvslutadAkut koronarsyndromSpanien
-
Guy's and St Thomas' NHS Foundation TrustOkändKranskärlssjukdom | Bröstsmärta | Akut koronarsyndrom | Ischemisk hjärtsjukdomStorbritannien
-
University of Texas Southwestern Medical CenterAvslutadAkut bröstsmärtaFörenta staterna
-
University of Texas Southwestern Medical CenterRekrytering