Use of Drug-Coated Balloon to Improve Recanalization of a Coronary Chronic Total Occlusion After Failed Angioplasty

Chronic Total Occlusion Clinical Trial

— IMPROVED-RECTO  

Official title:

Use of Drug-Coated Balloon to Improve Recanalization of a Coronary Chronic Total Occlusion After Failed Angioplasty: The IMPROVED-RECTO Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05158686
• Other study ID #: ICICOR-IMPROVED-RECTO-2021
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Total Occlusion

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