To compare stent expansion after plaque modification by IVL or balloon predilation in severely calcified coronary lesions assessed by optical coherence tomography (OCT).
ID
Source
Brief title
Condition
- Coronary artery disorders
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Stent expansion measured by OCT
Secondary outcome
1. Periprocedural and in-hospital complications
a. Coronary dissection type D-F,
b. Coronary perforation,
c. Periprocedural infarction (Troponin T rise of >5 times ULN, or a 20%
increase if already elevated but stable or falling); assessment if indicated
2. MACE at 1 month, 1- and 2-year FU, comprised of death, myocardial
infarction, or target-lesion revascularization and each of its individual
components
3. Stent thrombosis according the ARC criteria: defined as
a. Definite or confirmed stent thrombosis: Angiographic confirmation of vessel
occlusion or thrombus formation within, or adjacent to, the stented segment or
proven stent thrombosis at autopsy.
b. Probable stent thrombosis: Unexplained death within 30 days or target vessel
recurrent MI without angiographic confirmation.
c. Possible stent thrombosis: Unexplained death after 30 days.
Background summary
In percutaneous coronary intervention (PCI), severe coronary artery
calcification is associated with stent underexpansion, which is an independent
predictor for future adverse cardiac events. Intravascular lithotripsy (IVL) is
a promising modality for plaque modification that may improve stent expansion.
Study objective
To compare stent expansion after plaque modification by IVL or balloon
predilation in severely calcified coronary lesions assessed by optical
coherence tomography (OCT).
Study design
Prospective, randomized pilot study
Intervention
IVL or balloon dilatation, followed by stenting with DES in all patients
Study burden and risks
The burden for this study is negligible. Indication for treatment by PCI is
already set before inclusion in the study. Available data on IVL have shown no
additional risks are associated with this device. No *new* or developmental
techniques are used. Follow-up is by telephone, no extra visits nor associated
costs are necessary.
Oosterpark 9
Amsterdam 1091AC
NL
Oosterpark 9
Amsterdam 1091AC
NL
Listed location countries
Age
Inclusion criteria
1. Age >= 18 years
2. An indication for PCI of a calcified lesion in an native coronary artery
3. Main OCT criterium is a calcification score of 4 defined as maximum calcium
angle of >180 degrees, maximum calcium thickness >0.5mm, and a minimal calcium
length of 5mm, as measured at the target lesion
4. Written informed consent with agreement of follow-up visits.
5. Eligible for PCI with a target vessel reference diameter between 2.5 and 4.0
mm (by visual estimation).
Exclusion criteria
1. Severe congestive heart failure, severe heart failure NYHA IV
2. ST-elevation myocardial infarction as indication for PCI
3. Severe renal impairment with a glomerular filtration rate of <30ml/min/1.73m2
4. Lesion related exclusion criteria
5. Stent occlusion / restenosis
6. OCT images not fulfilling inclusion criteria
7. Inability to cross the lesion with an OCT catheter
8. Large side branch (>2.0mm) originating from the target lesion
9. Contraindication for dual antiplatelet therapy.
10. Recent history of major bleeding, hematologic disease and/or platelet count
< 100.000 per 1 mm3
11. Planned major surgery within 3 months after the procedure.
12. Participation in another clinical study, interfering with this protocol.
13. The inability to provide written informed consent.
14. Expected life expectancy of less than two years.
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 | NL72279.018.20 |