To establish baseline predictive factors for acute and late lumen growth after successful opening of chronic total occlusions. Secondary objectives are:1) Identifying the relation between change in absolute microvascular resistance and late change…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Changes in mean lumen diameter of the treated vessel, measured up to 5 mm
distal to the stent after recanalization and at 3 months follow-up
2) Changes in mean lumen diameter of the treated vessel, measured up to 5 mm
distal to the occlusion before recanalization and distal to the stent after
recanalization
3) Changes in collateral function, using the equation ((Pw-Pv))/((Pa-Pv)), in
rest and hyperaemic state, measured before recanalization, after recanalization
and at 3 months follow-up.
Secondary outcome
1) Changes in microvascular resistance after recanalization and at 3 months
follow-up
2) Stent malapposition at 3 months follow-up
3) Changes in the scoring of the SAQ before recanalization and at 3 months
follow-up
Background summary
Revascularization of a chronic total occlusion (CTO) has gained popularity last
decade. After recanalization there is an acute gain in vessel diameter, as well
as a late lumen gain distal to the stent as a result of positive remodeling.
The evolution of a recanalized CTO-vessel is however diverse. Several studies
are performed to measure distal lumen gain and hemodynamic coronary parameters
of a recanalized CTO, including the novel measurement Absolute Flow. Although
the results seem promising, an association between those parameters and distal
vessel lumen gain has never been found. Therefore, the aim of this study is to
understand the remodeling of the distal coronary vessel in relation with
hemodynamic coronary parameters, establishing baseline predictive factors,
adding new information about coronary physiology.
Study objective
To establish baseline predictive factors for acute and late lumen growth after
successful opening of chronic total occlusions.
Secondary objectives are:
1) Identifying the relation between change in absolute microvascular resistance
and late change distal lumen diameter from the end of the index procedure to 3
months follow-up
2) Identifying the relation between late lumen growth and stent malapposition,
assessed using Optical Coherence Tomography (OCT)
3) Identifying the relation between angina-related symptoms, assessed using the
Seattle Angina Questionnaire (SAQ), and absolute microvascular resistance.
Study design
A single-center, prospective, observational cohort study. The center performing
this study will be the Radboudumc.
Study burden and risks
Participants scheduled for revascularization of a CTO, receive standard care.
Complications as a result of coronary angiography performed at 3 months
follow-up are limited. The complication rate of the additional measurements is
low. Therefore, the additional measurements are considered low risk. On the
other hand, this study may provide valuable information on changes of
procedural success.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
- Scheduled elective revascularization procedure of a CTO, defined as a
complete obstruction of a coronary artery with TIMI-0 or TIMI-1 flow and
occlusion duration of at least 3 months
- Heart-team consensus for the indication of a CTO treatment, based on
viability and ischemia testing (using TTE or MRI)
- Able to give valid, written informed consent
Exclusion criteria
- Unsuccessful crossing of the lesion during PCI
- Renal insufficiency defined as eGFR < 30 ml/min
- Contra-indications to intravenous adenosine
- < 18 years of age
- Pregnancy
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 | NL76417.091.21 |