search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Drug-Eluting Balloon vs Conventional Balloon Pre-dilatation: An Open Randomized Trial in Acute Myocardial Infarction.


- candidate number8126
- NTR NumberNTR2363
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jun-2010
- Secondary IDsNL32405.075.10 / 32405 ; CCMO / ABR
- Public TitleDrug-Eluting Balloon vs Conventional Balloon Pre-dilatation: An Open Randomized Trial in Acute Myocardial Infarction.
- Scientific TitleSafety and efficacy of the Genous Bio-engineered R Stent™ pre-dilated with paclitaxel-eluting balloon (Pantera®) versus the Genous Bio-engineered R Stent™ pre-dilated with non drug eluting balloon in Patients undergoing PCI for ST-segment Elevation Myocardial Infarction.
- ACRONYMDEBORA2
- hypothesisThe primary objective of this randomized trial is to assess the Safety and efficacy of the Genous Bio-engineered R Stent™ pre-dilated with paclitaxel-eluting balloon (Pantera®) versus the Genous Bio-engineered R Stent™ pre-dilated with non drug eluting balloon in the Treatment of Patients with ST-segment Elevation Myocardial Infarction, undergoing PCI.
- Healt Condition(s) or Problem(s) studiedAcute myocardial infarction , Percutaneous Coronary Intervention (PCI), Stent, Drug eluting balloon
- Inclusion criteria1. Males or females 18 years of age or older and under 80 years with symptoms of AMI of more than 30 minutes but less than 24 hours;
2. ST segment elevation of > 1 mV in 2 adjacent ECG leads, with cumulative ST segment deviation of 6 mm or more.
- Exclusion criteria1. Women of child-bearing potential;
2. Severe hepatic or renal disease;
3. Previous participation in the study;
4. Life expectancy of < 1 year;
5. Factors making follow-up difficult;
6. AMI pre-treated with thrombolysis;
7. Patients who have previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies (HAMA);
8. Known sensitivity to aspirin, clopidogrel, or coumadin;
9. Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated;
10. Unable to provide informed consent.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2011
- planned closingdate1-apr-2013
- Target number of participants128
- Interventions1. Genous™ Bio-engineered R Stent™ + non-DEB (non-drug eluting balloon);
2. Genous™ Bio-engineered R Stent™ + DEB (drug (Paclitaxel) eluting balloon Pantera®)).
- Primary outcomeLate loss at 9 month follow-up by quantitative coronary angiography.
- Secondary outcomeMajor adverse cardiac clinical events (death, re-infarction, target vessel revascularization) at 30 days, 9 and 12 months after treatment.
- TimepointsPatients participating in this trial followed at 30 days, 9 and 12 months post procedure.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES A. Kloosterman
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Harry Suryapranata
- Sponsor/Initiator Isala Klinieken, Locatie Weezenlanden, Department of Cardiology, University Medical Center St. Radboud
- Funding
(Source(s) of Monetary or Material Support)
Isala Klinieken, Maatschap Cardiologie
- PublicationsN/A
- Brief summaryAlthough DES for AMI seems to be safe and feasible, the risk of stent thrombosis remains disappointingly high, despite prolonged dual anti-platelet therapy. Therefore, rapid-stent re-endothelialization, by capturing patient’s own circulating EPC’s may potentially reduce inflammatory, stent thrombosis, and restenosis. It has been shown that the higher the circulatory ECP’s the lower the late loss, whereas high EPC levels have been observed in the setting of AMI. The use of Genous stent after pre-dilatation with Paclitaxel-eluting balloon (to prevent restenosis) seems to be an ideal combination for the treatment of AMI patients.
- Main changes (audit trail)
- RECORD8-jun-2010 - 13-apr-2011


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl