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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05158686

Acronym

IMPROVED-RECTO

Enrollment

Registered

2021-12-15

Start date

2018-10-01

Completion date

2021-12-01

Last updated

2022-04-22

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

Conditions

Chronic Total Occlusion

Keywords

Repeated procedure, Angioplasty, Paclitaxel, drug-coated balloon

Brief 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.

Interventions

DEVICEPaclitaxel-coated Balloon dilation angioplasty

Paclitaxel-coated ballon dilation angioplasty proximal to CTO lesion after failed percutaneous recanalization

DEVICENon-coated Balloon dilation angioplasty

Non-coated ballon dilation angioplasty proximal to CTO lesion after failed percutaneous recanalization

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Success of repeated percutaneous coronary intervention of a CTO 3 to 6 months after balloon angioplasty proximal to the persistent lesion.	6 months

Secondary

Measure	Time frame	Description
Quality of life assessed by EQ5D questionnaire	6 months	—
Procedural duration during second attempt	6 months	—
Mortality after second attempt of CTO recanalization	6 months	—
Contrast administration during second attempt	6 months	—
Events at 1-year follow-up	1 year	All events including: Death, stroke, myocardial infarction (MI), target lesion revascularization (TLR), and contrast-induced nephropathy (CIN)
Radiation during second attempt	6 months	—

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026