Chronic Total OcclusionIMPROVED-RECTONCT05158686
Use of Drug-Coated Balloon to Improve Recanalization of a Coronary Chronic Total Occlusion After Failed Angioplasty
An observational study of Chronic Total Occlusion, run by Ignacio J. Amat Santos at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion
- What is being tested?
- Paclitaxel-coated Balloon dilation angioplasty and Non-coated Balloon dilation angioplasty
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2018to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary angiography in which percutaneous coronary intervention results in failure during treatment of a CTO. Indication of the procedures will be clinically driven. Informed consent will be provided after the first failed attempt of CTO recanalization.
Who may be able to join
- 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.
Who cannot join
- Unfeasible recanalization of the CTO according to the interventional cardiologists of the center.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Drug-Coated Balloon to Improve Recanalization of a Coronary Chronic Total Occlusion After Failed Angioplasty: The IMPROVED-RECTO Trial.
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.
- Conditions
- Chronic Total Occlusion
- Being tested
- Paclitaxel-coated Balloon dilation angioplasty, Non-coated Balloon dilation angioplasty
- Keywords
- Repeated procedure, Angioplasty, Paclitaxel, drug-coated balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel-coated Balloon dilation angioplastyDevice
Paclitaxel-coated ballon dilation angioplasty proximal to CTO lesion after failed percutaneous recanalization
Non-coated Balloon dilation angioplastyDevice
Non-coated ballon dilation angioplasty proximal to CTO lesion after failed percutaneous recanalization
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel-coated balloon angioplasty | Patients with previous failed recanalization of a CTO treated with paclitaxel coated balloon immediately proximal to the CTO during the index procedure Receives: Device: Paclitaxel-coated Balloon dilation angioplasty | |
| Non-coated balloon angioplasty | Patients with previous failed recanalization of a CTO treated with non-coated balloon immediately proximal to the CTO during the index procedure Receives: Device: Non-coated Balloon dilation angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of repeated percutaneous coronary intervention of a CTO 3 to 6 months after balloon angioplasty proximal to the persistent lesion.
Measured: 6 months
Secondary outcomes (6)
Mortality after second attempt of CTO recanalization
Measured: 6 months
Quality of life assessed by EQ5D questionnaire
Measured: 6 months
Procedural duration during second attempt
Measured: 6 months
Radiation during second attempt
Measured: 6 months
Contrast administration during second attempt
Measured: 6 months
Events at 1-year follow-up
All events including: Death, stroke, myocardial infarction (MI), target lesion revascularization (TLR), and contrast-induced nephropathy (CIN)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start1 Oct 2018
- Primary completion1 Oct 2020
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ignacio J. Amat Santos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ignacio J. Amat Santos, Hospital Clínico Universitario de Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158686
- Sponsor's protocol ID
- ICICOR-IMPROVED-RECTO-2021
- Acronym
- IMPROVED-RECTO
- Status last verified
- Apr 2022
- First submitted
- 2 Dec 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Drug-Coated Balloon to Improve Recanalization of a Coronary Chronic Total Occlusion After Failed Angioplasty: The IMPROVED-RECTO Trial.
- ClinicalTrials.gov ID
- NCT05158686
- Acronym / sponsor ID
- IMPROVED-RECTO / ICICOR-IMPROVED-RECTO-2021
- Conditions
- Chronic Total Occlusion
- Keywords
- Repeated procedure, Angioplasty, Paclitaxel, drug-coated balloon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ignacio J. Amat SantosUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel-coated balloon angioplasty | – | Device: Paclitaxel-coated Balloon dilation angioplastyPatients with previous failed recanalization of a CTO treated with paclitaxel coated balloon immediately proximal to the CTO during the index procedure |
| Non-coated balloon angioplasty | – | Device: Non-coated Balloon dilation angioplastyPatients with previous failed recanalization of a CTO treated with non-coated balloon immediately proximal to the CTO during the index procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary angiography in which percutaneous coronary intervention results in failure during treatment of a CTO. Indication of the procedures will be clinically driven. Informed consent will be provided after the first failed attempt of CTO recanalization.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Unfeasible recanalization of the CTO according to the interventional cardiologists of the center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel-coated Balloon dilation angioplastyPaclitaxel-coated ballon dilation angioplasty proximal to CTO lesion after failed percutaneous recanalization | Device | Paclitaxel-coated balloon angioplasty |
| Non-coated Balloon dilation angioplastyNon-coated ballon dilation angioplasty proximal to CTO lesion after failed percutaneous recanalization | Device | Non-coated balloon angioplasty |
Primary outcome
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
6 secondary outcomes
Mortality after second attempt of CTO recanalization
Time frame: 6 months
Quality of life assessed by EQ5D questionnaire
Time frame: 6 months
Procedural duration during second attempt
Time frame: 6 months
Radiation during second attempt
Time frame: 6 months
Contrast administration during second attempt
Time frame: 6 months
Events at 1-year follow-up
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Total Occlusion, run by Ignacio J. Amat Santos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.