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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05158686
Other study ID # ICICOR-IMPROVED-RECTO-2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date December 1, 2021

Study information

Verified date April 2022
Source Hospital Clínico Universitario de Valladolid
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Observational retrospective registry to compare effectiveness of paclitaxel-coated vs. non coated balloon angioplasty proximal to a Chronic Total Occlussion (CTO) after failed revascularization. Primary objective is to determine success rate after repeated percutaneous coronary intervention of a CTO 3 to 6 months after paclitaxel-coated balloon angioplasty proximal to the persistent lesion.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date December 1, 2021
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Failed recanalization of a CTO in patients with clinical indication for the percutaneous procedure. - Patient willing to participate in the study providing signed informed consent. - J-CTO Score =2. Exclusion Criteria: - Unfeasible recanalization of the CTO according to the interventional cardiologists of the center.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Paclitaxel-coated Balloon dilation angioplasty
Paclitaxel-coated ballon dilation angioplasty proximal to CTO lesion after failed percutaneous recanalization
Non-coated Balloon dilation angioplasty
Non-coated ballon dilation angioplasty proximal to CTO lesion after failed percutaneous recanalization

Locations

Country Name City State
Spain Hospital Clínico Universitario de Valladolid Valladolid

Sponsors (1)

Lead Sponsor Collaborator
Ignacio J. Amat Santos

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success of repeated percutaneous coronary intervention of a CTO 3 to 6 months after balloon angioplasty proximal to the persistent lesion. 6 months
Secondary Mortality after second attempt of CTO recanalization 6 months
Secondary Quality of life assessed by EQ5D questionnaire 6 months
Secondary Procedural duration during second attempt 6 months
Secondary Radiation during second attempt 6 months
Secondary Contrast administration during second attempt 6 months
Secondary Events at 1-year follow-up All events including: Death, stroke, myocardial infarction (MI), target lesion revascularization (TLR), and contrast-induced nephropathy (CIN) 1 year
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