Remodeling of distal coronary vessel in chronic total occlusions: prediction based on hemodynamic coronary parameters

Remodeling of distal coronary vessel in chronic total occlusions: prediction based on hemodynamic coronary parameters - CTO-VR

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51242

Enrollment

Registered

2021-05-19

Start date

2021-12-16

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Total Occlusie coronary artery disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Unsuccessful crossing of the lesion during PCI - Renal insufficiency defined as eGFR

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Netherlands

Outcome results