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Completed

NCT Number: NCT05158686

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

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.

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Key information

Conditions

Chronic Total Occlusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paclitaxel-coated Balloon dilation angioplasty

Device

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

Non-coated Balloon dilation angioplasty

Device

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

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. Mortality after second attempt of CTO recanalization

    Time frame: 6 months

  2. Quality of life assessed by EQ5D questionnaire

    Time frame: 6 months

  3. Procedural duration during second attempt

    Time frame: 6 months

  4. Radiation during second attempt

    Time frame: 6 months

  5. Contrast administration during second attempt

    Time frame: 6 months

  6. Events at 1-year follow-up

    Time frame: 1 year

    All events including: Death, stroke, myocardial infarction (MI), target lesion revascularization (TLR), and contrast-induced nephropathy (CIN)

Sponsors and collaborators

Lead sponsor

Ignacio J. Amat Santos

Other

Registry information

Official study title

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

Acronym: IMPROVED-RECTO

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Dec 15, 2021
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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