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Drug-Coated Balloon Only Strategy After Recanalization of Chronic Total Coronary Occlusions

ConditionsAngina (Stable)Coronary OcclusionCoronary Artery DiseaseChronic Total Occlusion
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital

About this trial

Chronic total occlusions (CTO) of the coronary arteries are usually treated with drug-eluting stents (DES) after successful recanalization. Permanent metallic scaffolds carry recognized long-term limitations, including late malapposition, very late stent thrombosis, impairment of positive vascular remodeling, and edge restenosis after geographic miss. Drug-coated balloons (DCB) deliver an antiproliferative agent to the vessel wall without leaving a permanent implant, and may be particularly attractive in long, fibrocalcific recanalized CTO segments.

NoTrace-CTO is a prospective, single-center, investigator-initiated, single-arm pilot study evaluating an exclusive DCB-only strategy, with no stent implantation, after successful CTO recanalization. Thirty-eight patients are planned, to yield thirty evaluable patients with paired angiographic follow-up.

The primary endpoint is in-balloon late lumen loss at nine months, measured by quantitative coronary angiography (QCA) and tested against a pre-specified performance goal of 0.50 mm derived from a pooled contemporary second-generation DES benchmark. The proportion of lesions completing the DCB-only strategy without bailout stenting is reported descriptively alongside it. Serial intravascular ultrasound (IVUS) performed at baseline, immediately after DCB delivery and at nine months is the mechanistic centerpiece of the study, assessing vascular remodeling directly. Secondary assessments include quantitative flow ratio (QFR), Seattle Angina Questionnaire (SAQ) scores, binary restenosis, reocclusion, target lesion and target vessel revascularization, major adverse cardiovascular events (MACE), bleeding classified by the Bleeding Academic Research Consortium (BARC) criteria, and acute kidney injury defined by the Kidney Disease: Improving Global Outcomes (KDIGO) criteria.

The study is not powered for comparative clinical superiority or non-inferiority against DES; its findings are hypothesis-generating and intended to inform the design of an adequately powered multicenter trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Chronic total coronary occlusion (CTO) of more than three months' duration, confirmed by prior angiography or lesion characteristics

Clinical indication for revascularization, defined as limiting angina and/or documented ischemia

Successful CTO recanalization, defined as restoration of Thrombolysis in Myocardial Infarction (TIMI) grade 3 antegrade flow and absence of any flow-limiting dissection

Disqualifiers

Acute coronary syndrome or cardiogenic shock at presentation

Flow-limiting dissection (TIMI grade below 3) requiring stent implantation

Left main coronary artery as the CTO target vessel

Reference vessel diameter below 2.0 mm or above 4.0 mm

Trial design

Design model

Single group

Treatments tested in this trial

  • Paclitaxel-coated balloon (AGENT Paclitaxel-Coated PTCA Balloon Catheter)

    Device

    Paclitaxel-coated balloon at a dose density of 2 micrograms/mm2, sized 1:1 to the intravascular ultrasound (IVUS) measured reference vessel diameter and of sufficient length to cover the full treated segment. Each inflation is maintained for a minimum of 120 seconds at nominal pressure. Where more than one balloon is required for full longitudinal coverage, each inflation independently meets the minimum duration with at least 2 mm of documented overlap.

  • Serial intravascular ultrasound and protocol-mandated nine-month angiographic reassessment

    Procedure/Surgery

    Intravascular ultrasound with automated motorized pullback at 0.5 mm/s is performed before and immediately after drug-coated balloon angioplasty and repeated at nine months, together with elective diagnostic coronary angiography of the target vessel, to quantify late lumen loss and serial vascular remodeling. Patients declining invasive reassessment may be offered coronary computed tomography angiography as a non-invasive fallback.

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: DCB-only strategyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

In-balloon late lumen loss at nine months

Difference between the minimal luminal diameter measured by quantitative coronary angiography immediately after the index procedure and the minimal luminal diameter at nine-month follow-up angiography. This is the sole endpoint against which the pre-specified performance goal of 0.50 mm is formally tested, using the upper bound of the one-sided 97.5% confidence interval, in the per-protocol population.

Time frame
9 months
2

DCB-only strategy success

Proportion of enrolled, successfully recanalized lesions treated exclusively with a drug-coated balloon without bailout stent implantation, defined consistent with Drug-Coated Balloon Academic Research Consortium recommendations and calculated on the full intention-to-treat denominator. Reported descriptively with an exact Clopper-Pearson 95% confidence interval; not hypothesis-tested against a performance goal.

Time frame
Periprocedural

Secondary outcomes

1

In-segment late lumen loss at nine months

Late lumen loss measured across the analysis segment including the 5 mm proximal and distal margins adjacent to the treated segment, reported as a supportive quantitative coronary angiography measure.

Time frame
9 months
2

Change in quantitative flow ratio

Quantitative flow ratio (QFR) derived by the frame-count contrast-flow method from at least two angiographic projections separated by 25 degrees or more, with intracoronary nitrate administered before each acquisition, compared between the post-procedural baseline and nine-month follow-up. Exploratory and hypothesis-generating. Unit of Measure: ratio

Time frame
Periprocedural and 9 months
3

In-balloon binary angiographic restenosis at 9 months

Percent diameter stenosis of 50% or greater within the in-balloon analysis segment at follow-up angiography, defined consistent with Drug-Coated Balloon Academic Research Consortium (DCB-ARC) recommendations and reported as a proportion of lesions with a 95% confidence interval. Unit of Measure: percentage of lesions

Time frame
9 months
4

In-segment binary angiographic restenosis at 9 months

Percent diameter stenosis of 50% or greater within the in-segment analysis segment, which includes the 5 mm proximal and distal margins adjacent to the treated segment, at follow-up angiography, defined consistent with Drug-Coated Balloon Academic Research Consortium (DCB-ARC) recommendations and reported as a proportion of lesions with a 95% confidence interval. Unit of Measure: percentage of lesions

Time frame
9 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo General Hospital

Lead sponsor

Boston Scientific Corporation

Collaborator

Source ClinicalTrials.gov

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