No registrations found.
ID
Source
Brief title
Health condition
Acute Myocardial Infarction
PCI
Drug eluting balloon
stent
Sponsors and support
dr. H. Suryapranata
Groot Wezenland 20
8011 JW Zwolle
Intervention
Outcome measures
Primary outcome
Primary endpoint:
- Late loss at 9 month follow-up by quantitative coronary angiography.
Secondary outcome
Secondary endpoint:
Major adverse cardiac clinical events (death, re-infarction, target vessel revascularization) at 1, 9 and 12 months after treatment.
Background summary
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.
Study objective
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
Study design
Start of trial: October 2008
End of randomization: October 2009
Complete 12-month follow-up October 2010
Intervention
- Genous™ Bio-engineered R Stent™ + non-DEB
(non-drug eluting balloon)
- Genous™ Bio-engineered R Stent™ + DEB
(drug (Paclitaxel) eluting balloon (Dior™))
A. Kloosterman
van Nahuysplein 6
Zwolle 8011 NB
The Netherlands
+31 (0)38 4262999
a.kloosterman@diagram-zwolle.nl
A. Kloosterman
van Nahuysplein 6
Zwolle 8011 NB
The Netherlands
+31 (0)38 4262999
a.kloosterman@diagram-zwolle.nl
Inclusion criteria
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
Exclusion criteria
- 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1500 |
| NTR-old | NTR1570 |
| Other | NL24841.075.08 : ABR |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |