Safety and efficacy of the Genous Bio-engineered R Stent™ pre-dilated with paclitaxel-eluting balloon (Dior™) versus the Genous Bio-engineered R Stent™ pre-dilated with non drug eluting balloon in Patients undergoing PCI for ST-segment Elevation…
ID
Bron
Verkorte titel
Aandoening
Acute Myocardial Infarction
PCI
Drug eluting balloon
stent
Ondersteuning
dr. H. Suryapranata
Groot Wezenland 20
8011 JW Zwolle
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Primary endpoint: <br>
- Late loss at 9 month follow-up by quantitative coronary angiography.
Achtergrond van het onderzoek
Although 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.
Doel van het onderzoek
Safety and efficacy of the Genous Bio-engineered R Stent™ pre-dilated with paclitaxel-eluting balloon (Dior™) versus the Genous Bio-engineered R Stent™ pre-dilated with non drug eluting balloon in Patients undergoing PCI for ST-segment Elevation Myocardial Infarction
Onderzoeksopzet
Start of trial: October 2008
End of randomization: October 2009
Complete 12-month follow-up October 2010
Onderzoeksproduct en/of interventie
- Genous™ Bio-engineered R Stent™ + non-DEB
(non-drug eluting balloon)
- Genous™ Bio-engineered R Stent™ + DEB
(drug (Paclitaxel) eluting balloon (Dior™))
Publiek
A. Kloosterman
van Nahuysplein 6
Zwolle 8011 NB
The Netherlands
+31 (0)38 4262999
a.kloosterman@diagram-zwolle.nl
Wetenschappelijk
A. Kloosterman
van Nahuysplein 6
Zwolle 8011 NB
The Netherlands
+31 (0)38 4262999
a.kloosterman@diagram-zwolle.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Males or females > 18 years of age and < 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Women of child-bearing potential
1. Severe hepatic or renal disease
2. Previous participation in the study
3. Life expectancy of < 1 year
4. Factors making follow-up difficult
5. AMI pre-treated with thrombolysis
6. Patients who have previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-Murine Antibodies (HAMA)
7. Known sensitivity to aspirin, clopidogrel, or coumadin
8. Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated
9. Unable to provide informed consent
ANGIOGRAPHIC EXCLUSION CRITERIA
1. Unprotected left main disease or single remaining vessel
2. Target lesion in a bifurcation with a large side-branch
3. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent
4. Patients with coronary vessel diameter of < 2.50 mm or > 4.0 mm
5. Patients with lesions located in saphenous vein grafts
6. Patients with diffuse disease or poor flow distal to the target lesions
7. Patients with tortuous vessels in the region of the obstruction or proximal to the lesion
8. Patients treated with drug-eluting stents
9. Patients previously treated with drug-eluting balloon
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1500 |
| NTR-old | NTR1570 |
| Ander register | NL24841.075.08 : ABR |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |