Clinical Research Directory
Browse clinical research sites, groups, and studies.
Drug-Coated Balloon Only Strategy After Recanalization of Chronic Total Coronary Occlusions
Sponsor: University of Sao Paulo General Hospital
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2026-11
Completion Date
2028-06
Last Updated
2026-09-14
Healthy Volunteers
No
Interventions
Paclitaxel-coated balloon (AGENT Paclitaxel-Coated PTCA Balloon Catheter)
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
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.
Locations (1)
InCor - Instituto do Coracao - University of Sao Paulo Heart Institute
São Paulo, São Paulo, Brazil