Remodeling of distal coronary vessel in chronic total occlusions: prediction based on hemodynamic coronary parameters
Recruiting
- Conditions
- Chronic Total Occlusiecoronary artery disease10011082
- Registration Number
- NL-OMON51242
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1) Changes in mean lumen diameter of the treated vessel, measured up to 5 mm<br /><br>distal to the stent after recanalization and at 3 months follow-up<br /><br>2) Changes in mean lumen diameter of the treated vessel, measured up to 5 mm<br /><br>distal to the occlusion before recanalization and distal to the stent after<br /><br>recanalization<br /><br>3) Changes in collateral function, using the equation ((Pw-Pv))/((Pa-Pv)), in<br /><br>rest and hyperaemic state, measured before recanalization, after recanalization<br /><br>and at 3 months follow-up.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1) Changes in microvascular resistance after recanalization and at 3 months<br /><br>follow-up<br /><br>2) Stent malapposition at 3 months follow-up<br /><br>3) Changes in the scoring of the SAQ before recanalization and at 3 months<br /><br>follow-up</p><br>