NCT07817719Not yet recruiting
Drug-Coated Balloon Only Strategy After Recanalization of Chronic Total Coronary Occlusions
NoTrace-CTO: Exclusive Drug-Coated Balloon Use After Recanalization of Chronic Total Coronary Occlusions - A Prospective, Single-Center, Single-Arm Study With Paired Quantitative Coronary Angiography and Serial Intravascular Ultrasound
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- First submitted
- 1 Sept 2026
- Start date
- Nov 2026
- Primary completion date
- Feb 2028
- Lead sponsor
- University of Sao Paulo General Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07817719
What you commit to
- Study type: Interventional
- Planned participants: 38
- From Nov 2026 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Absolute contraindication to dual antiplatelet therapy for the protocol-defined duration of 3 to 6 months
Other illness
- Acute coronary syndrome or cardiogenic shock at presentation
- Inability to achieve adequate lesion preparation, defined as absence of flow-limiting or otherwise significant dissection and satisfactory conditions for drug delivery, confirmed by angiography and intravascular ultrasound (IVUS)
Other
- 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
- In-stent chronic total occlusion
Who the study is looking for
- 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
- Life expectancy greater than one year
- Written informed consent provided
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| InCor - Instituto do Coracao - University of Sao Paulo Heart Institute Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.