To evaluate and compare the procedural time of two stent delivery systems for PCI with EES.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the proportion of procedures with crossing time (from
introduction of guidewire to stent deployment) longer than 30 minutes.
Secondary outcome
Secondary endpoints include procedural time (from heparin administration to
removal of catheter sheath, mins), use of additional materials, total
procedural costs, radiation dose (*Gym2), radiation time (mins), and contrast
dose (ml).
Background summary
The current gold standard for percutaneous coronary intervention (PCI) is the
second generation drug-eluting stent (DES). The most commonly used DES is the
everolimus-eluting stent (EES). New stent delivery systems for PCI with EES are
developed to optimize strength, flexibility and pushability of the catheter.
The effect of new stent delivery systems on procedural time has not yet been
investigated in clinical practice.
Study objective
To evaluate and compare the procedural time of two stent delivery systems for
PCI with EES.
Study design
Randomized comparative trial with 500 patients in the University Medical Center
Groningen (UMCG).
Intervention
The first group will undergo PCI with the XIENCE EES using the Alpine stent
delivery system, the second group will undergo PCI with the Xpedition stent
delivery system.
Study burden and risks
Both stent delivery systems have received CE marking, are commercially
available and are used within their indication. Both stent delivery systems use
identical stents, meaning that the treatment given to both study groups is
equivalent and patients will not be exposed to additional burdens or risks.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
All patients undergoing PCI with EES, aged 18 years or older, will be considered for eligibility.
Exclusion criteria
Patients will be excluded when scheduled for chronic total occlusion (CTO) PCI or if verbal informed consent cannot be obtained.
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 |
|---|---|
| CCMO | NL60872.042.17 |