Invest-CTO: Effectiveness and Safety of a Planned Investment Procedure in High-Risk CTO PCI

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Following unsuccessful CTO crossing a CTO modification procedure is sometimes performed. CTO PCI registries where plaque modification has been performed in some patients, report this to be safe, and associated with higher success rates at subsequent attempts. It has never been investigated whether a planned investment procedure, with an intention that both the initial and staged completion PCI are of shorter duration, could improve safety and efficacy. The investigators hypothesize that 1. A planned investment procedure in the treatment of CTOs will be associated with improved patient safety 2. A planned investment procedure will be associated with improved cumulative procedure success rates 3. A planned two stage procedure will be associated with improved patient experience

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Ability to provide written informed consent

• Comply with the procedural and study follow-up schedule

• Planned CTO PCI in accordance with the European and American appropriateness criteria.

• CTO defined as high-risk

Locations
United States
New York
Columbia University Medical Center/ NewYork Presbyterian Hospital
RECRUITING
New York
Other Locations
Norway
Haukeland University Hospital
RECRUITING
Bergen
United Kingdom
Bristol Health
RECRUITING
Bristol
Golden Jubilee National Hospital
RECRUITING
Glasgow
St George´s Hospital
RECRUITING
London
Contact Information
Primary
Anja Øksnes, MD
anao@helse-bergen.no
+4755975000
Time Frame
Start Date: 2021-12-08
Estimated Completion Date: 2026-10
Participants
Target number of participants: 200
Treatments
Experimental: Invest CTO PCI
A pre-planned two staged procedure in high-risk CTO PCI
Sponsors
Leads: Haukeland University Hospital
Collaborators: Golden Jubilee National Hospital

This content was sourced from clinicaltrials.gov

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