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In-stent RestenosisNCT05731700

CVT-ISR First in Human Trial for Coronary In-Stent Restenosis

A study testing Drug Eluting Balloon in people with In-stent Restenosis, run by Abbott Medical Devices at 9 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this first in human study is to assess the safety and inhibition of restenosis of the CVT Everolimus-coated PTCA Catheter in the treatment of subjects presenting in-stent restenotic lesions in native coronary arteries. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
In-stent Restenosis
What is being tested?
Drug Eluting Balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
9 sitesin 4 countries
Study dates
20 Oct 2021to 8 May 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Subject must be at least 18 years of age.
  • Subject or his/her legally authorized representative provides written informed consent prior to any clinical investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site.
  • Subject must agree to undergo all clinical investigation plan-required follow-up visits, angiograms, IVUS/OCT and examinations.
  • Angiographic Inclusion Criteria
  • Target lesion must be located within a stent (bare metal or drug eluting) placed in a native epicardial coronary vessel with visually estimated nominal vessel diameter of ≥2.0mm and ≤3.5mm.
  • Target lesion must measure ≤24 mm in length by visual estimation.
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  • The target lesion must be with a visually estimated stenosis of ≥50% and < 100% with a TIMI flow of ≥1.
  • Non-clinical investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done ≥90 days prior to or planned to be done 6 months after the index procedure.
  • Non-clinical investigation, percutaneous intervention for lesions in the target vessel is allowed if planned to be done 6 months after the index procedure.

Who cannot join

  • Subject with known diagnosis of acute myocardial infarction (AMI) within 30 days preceding the index procedure and CK-MB or troponin have not returned within normal limits at the time of procedure.
  • The subject is currently experiencing clinical symptoms consistent with AMI.
  • Subject has current unstable arrhythmia.
  • Subject has a known left ventricular ejection fraction (LVEF) <25%.
  • Subject has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine and structurally related compounds, everolimus, or contrast sensitivity that cannot be adequately pre-medicated.
  • Subject has known renal insufficiency (e.g., serum creatinine > 2.5 mg/dL, (i.e. 221 µmol/L) within 7 days prior to index procedure or creatinine clearance <30mL/min or subject is on dialysis.
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  • Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months.
  • Subject has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
  • Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.
  • Subject is not, in the opinion of the investigator, an acceptable candidate to participate in the study.
  • In-stent lesions for stent are located within an arterial or saphenous vein graft or stent used to treat a previous ISR.
  • The target vessel contains visible thrombus.
  • Pregnant or lactating females.

Trial locations and contacts

9 sites in 4 countries.

9 sites in 4 countries

France3 sites

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble, 38000

  • L'Hôpital Privé du Confluent

    Nantes, 44000

  • Clinique Pasteur

    Toulouse, 31300

Other trials in France

Spain3 sites

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital Universitario La Paz

    Madrid, 28046

Other trials in Spain

Georgia2 sites

  • Tbilisi Heart and Vascular Clinic

    Tbilisi, 0159

  • Georgian Israeli Research Medical Centre Helsicore

    Tbilisi

Other trials in Georgia

Lithuania1 site

  • Vilniaus universiteto ligoninė Santaros klinikos

    Vilnius, 08410

Other trials in Lithuania

About this study

Official title: Everolimus-Coated Percutaneous Transluminal Coronary Angioplasty Catheter First in Human Clinical Investigation: A Clinical Evaluation in the Treatment of Subjects With In-Stent Restenosis of Previously-treated Coronary Artery Lesions

The goal of this first in human study is to assess the safety and inhibition of restenosis of the CVT Everolimus-coated PTCA Catheter in the treatment of subjects presenting in-stent restenotic lesions in native coronary arteries.

Read the detailed description

The CVT-ISR Trial is a prospective, multi-center, open, single arm study enrolling subjects with visually estimated nominal vessel diameter ≥2.0 mm and ≤3.5mm and lesion length ≤24 mm receiving up to two (2) CVT Everolimus CVT EVE-PTCA Catheters.

An angiographic follow up, in combination with either Intravascular Ultrasound (IVUS) or Optical Coherence Tomography (OCT), follow-up, will be carried out in a subset of 25 patients at 180 days following the index procedure.

Being tested
Drug Eluting Balloon
Keywords
TP1125, Coronary, CVT, CVT-ISR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug Eluting BalloonDevice

    PCI of in-stent restenosis

Study groups in NCT05731700
Study groupRoleWhat they receive
Drug eluting balloonExperimentalTreatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Receives: Device: Drug Eluting Balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate

    Composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR).

    Measured: 6 months post-index procedure

  2. The Primary Effectiveness Endpoint for the CVT-ISR Study: In-stent Late Lumen Loss (LLL)

    In-Stent Late Lumen Loss (LLL) measures the reduction in the luminal diameter of a stented artery over a specified period after stent implantation, typically assessed using angiographic imaging. The unit of measurement for this outcome is expressed in millimeters (mm) or percentage (%), depending on the reporting method. The LLL is calculated by comparing the luminal diameter at a follow-up time point to the post-procedure luminal diameter.

    Measured: 180 days post-procedure

Secondary outcomes (9)

  1. Composite Rate of Target Lesion Failure (TLF)

    TLF is defined as composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR).

    Measured: 30 days post-procedure, 12 months, 24 months and 36 months

  2. Composite Rate of Target Vessel Failure (TVF)

    Target vessel failure (TVF) is defined as composite rate of cardiovascular death, target vessel myocardial infarction, and target vessel revascularization (TVR).

    Measured: 30 days post-procedure, 180 days, 12 months, 24 months and 36 months

  3. Clinically Driven Target Lesion Revascularization (TLR)

    TLR is defined as any repeat PCI of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.

    Measured: 12 months, 24 months and 36 months

  4. Clinically-driven Target Vessel Revascularization (TVR)

    TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.

    Measured: 180 days, 12 months, 24 months and 36 months

  5. Rate of Vascular Access Site Complications

    The rate of vascular access site complications is defined as the combined rate of hematoma, AV fistula or a pseudoaneurysm that required intervention, such as surgical repair, transfusion or a prolonged hospital stay or requiring a new hospital admittance.

    Measured: 12 months

  6. Lesion Success:

    Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of <30% (by QCA), using any device after wire passage through the lesion.

    Measured: 12 months

  7. Technical Success

    Technical success, defined as achievement of a final in-lesion residual diameter stenosis of <30% (by QCA), using the CVT Everolimus coated PTCA Catheter without a device malfunction after wire passage through the lesion.

    Measured: 12 months

  8. Clinical Success (Per Subject)

    Clinical success (per subject) defined as technical success without the occurrence of major adverse cardiac events during the procedure.

    Measured: 12 months

  9. Procedural Success

    Procedural success (per subject) defined as lesion success without the occurrence of major adverse cardiac events during the procedure.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2023
  2. Study start20 Oct 2021
  3. Primary completion19 Sep 2022
  4. Study completion8 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05731700
Sponsor's protocol ID
TP1125
Status last verified
Apr 2026
First submitted
25 Jan 2023
Last updated
15 May 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Alfonso F, Shaburishvili T, Farah B, Gogorishvili I, Monsegu J, Baranauskas A, Bressollette E, Shaburishvili G, Cuesta J, Rivero F, Moreno R, Sabate M. Three-Year Clinical Follow-Up of a Novel Everolimus-Coated Balloon for Patients With In-Stent Restenosis. Am J Cardiol. 2026 May 15;267:39-43. doi: 10.1016/j.amjcard.2026.02.044. Epub 2026 Feb 26.

    PubMed 41759564

  • Alfonso F, Shaburishvili T, Farah B, Gogorishvili I, Monsegu J, Baranauskas A, Bressollette E, Shaburishvili G, Cuesta J, Rivero F, Moreno R, Sabate M. First-in-man study of a novel everolimus-coated balloon for the treatment of coronary in-stent restenosis. Coron Artery Dis. 2025 Mar 1;36(2):91-98. doi: 10.1097/MCA.0000000000001459. Epub 2024 Nov 27.

    PubMed 39601687

Questions about this trial

What is this clinical trial studying?

A study testing Drug Eluting Balloon in people with In-stent Restenosis, run by Abbott Medical Devices at 9 sites in 4 countries.

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 9 inclusion and 14 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 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France, Spain, Georgia, Lithuania. 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?

Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate (time frame: 6 months post-index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05731700, which also lists 2 linked publications.

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 15 May 2026.

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