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

NCT07817719 | Not Yet Recruiting DMC

• 1 other identifier: 96316426.6.0000.0068
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Occlusion; Chronic Total Occlusion; Angina (Stable); Coronary Artery Disease

Keywords

Chronic total occlusion; Drug-coated balloon; Paclitaxel; Percutaneous coronary intervention; Late lumen loss; Intravascular ultrasound; Vascular remodeling; Leave nothing behind; Quantitative coronary angiography; Quantitative flow ratio

Outcome Measures

Primary Outcomes (2)

• 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.

  9 months

• 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.

  Periprocedural

Secondary Outcomes (20)

• In-segment late lumen loss at nine months

  9 months

• Change in quantitative flow ratio

  Periprocedural and 9 months

• In-balloon binary angiographic restenosis at 9 months

  9 months

• In-segment binary angiographic restenosis at 9 months

  9 months

• Target lesion reocclusion

  9 months

Study Arms (1)

DCB-only strategy

EXPERIMENTAL

Patients with successful chronic total occlusion (CTO) recanalization and adequate lesion preparation, confirmed by intravascular ultrasound (IVUS) and angiography, receive exclusive paclitaxel drug-coated balloon (DCB) treatment of the target lesion, with no permanent metallic scaffold implanted. Bailout stent implantation is performed only for flow-limiting dissection that cannot be optimized with repeat balloon inflation, and is classified as technical failure of the DCB-only strategy.

Device: Paclitaxel-coated balloon (AGENT Paclitaxel-Coated PTCA Balloon Catheter); Procedure: Serial intravascular ultrasound and protocol-mandated nine-month angiographic reassessment

Interventions

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.

Also known as: Drug-coated balloon (DCB), Drug-eluting balloon (DEB)

DCB-only strategy

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

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.

DCB-only strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• In-stent chronic total occlusion
• Absolute contraindication to dual antiplatelet therapy for the protocol-defined duration of 3 to 6 months
• 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)

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

InCor - Instituto do Coracao - University of Sao Paulo Heart Institute

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (4)

• Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.

  PMID: 32473887 BACKGROUND

• Mutlu D, Rempakos A, Strepkos D, Carvalho PEP, Alexandrou M, Kladou E, Ser OS, Azzalini L, Jaffer FA, Ybarra L, Goktekin O, Uluganyan M, Ozdemir R, Elbarouni B, Alaswad K, Davies R, ElGuindy A, Kocas C, Sural S, Poommipanit P, Frizzel J, Basir MB, Raj L, Young L, Rangan BV, Mastrodemos OC, Sara JDS, Jalli S, Sandoval Y, Burke MN, Brilakis ES, Gorgulu S. Drug-Coated Balloons in Chronic Total Occlusion Percutaneous Coronary Intervention: Insights From the PROGRESS-CTO Registry. Catheter Cardiovasc Interv. 2025 Dec;106(7):3783-3795. doi: 10.1002/ccd.70240. Epub 2025 Oct 13.

  PMID: 41084138 BACKGROUND

• Fezzi S, Scheller B, Cortese B, Alfonso F, Jeger R, Colombo A, Joner M, Shin ES, Kleber FX, Latib A, Rissanen TT, Eccleshall S, Ribichini F, Tao L, Koo BK, Chieffo A, Ge J, Granada JF, Stoll HP, Spaulding C, Cavalcante R, Abizaid A, Muramatsu T, Boudoulas KD, Waksman R, Mehran R, Cutlip DE, Krucoff MW, Stone GW, Garg S, Onuma Y, Serruys PW. Definitions and standardized endpoints for the use of drug-coated balloon in coronary artery disease: consensus document of the Drug Coated Balloon Academic Research Consortium. Eur Heart J. 2025 Jul 7;46(26):2498-2519. doi: 10.1093/eurheartj/ehaf029.

  PMID: 40270117 BACKGROUND

• Brilakis ES, Mashayekhi K, Tsuchikane E, Abi Rafeh N, Alaswad K, Araya M, Avran A, Azzalini L, Babunashvili AM, Bayani B, Bhindi R, Boudou N, Boukhris M, Bozinovic NZ, Bryniarski L, Bufe A, Buller CE, Burke MN, Buttner HJ, Cardoso P, Carlino M, Christiansen EH, Colombo A, Croce K, Damas de Los Santos F, De Martini T, Dens J, Di Mario C, Dou K, Egred M, ElGuindy AM, Escaned J, Furkalo S, Gagnor A, Galassi AR, Garbo R, Ge J, Goel PK, Goktekin O, Grancini L, Grantham JA, Hanratty C, Harb S, Harding SA, Henriques JPS, Hill JM, Jaffer FA, Jang Y, Jussila R, Kalnins A, Kalyanasundaram A, Kandzari DE, Kao HL, Karmpaliotis D, Kassem HH, Knaapen P, Kornowski R, Krestyaninov O, Kumar AVG, Laanmets P, Lamelas P, Lee SW, Lefevre T, Li Y, Lim ST, Lo S, Lombardi W, McEntegart M, Munawar M, Navarro Lecaro JA, Ngo HM, Nicholson W, Olivecrona GK, Padilla L, Postu M, Quadros A, Quesada FH, Prakasa Rao VS, Reifart N, Saghatelyan M, Santiago R, Sianos G, Smith E, C Spratt J, Stone GW, Strange JW, Tammam K, Ungi I, Vo M, Vu VH, Walsh S, Werner GS, Wollmuth JR, Wu EB, Wyman RM, Xu B, Yamane M, Ybarra LF, Yeh RW, Zhang Q, Rinfret S. Guiding Principles for Chronic Total Occlusion Percutaneous Coronary Intervention. Circulation. 2019 Jul 30;140(5):420-433. doi: 10.1161/CIRCULATIONAHA.119.039797. Epub 2019 Jul 29.

  PMID: 31356129 BACKGROUND

MeSH Terms

Conditions

Angina, Stable; Coronary Occlusion; Coronary Artery Disease; Vascular Remodeling

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Pathologic Processes

Study Officials

• Antonio D Freire, MD, PhD

  University of Sao Paulo Heart Institute - InCor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Estevao M Pardi, MD

CONTACT

+55 11 964863553; estevaopardi@gmail.com

Antonio D Freire, MD, PHD

CONTACT

antoniofdfreire@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm pilot study; all enrolled patients receive an exclusive drug-coated balloon strategy after successful chronic total occlusion recanalization, with no stent implantation unless bailout is required.

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 14, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 12 months after publication of the primary results and ending 5 years after that date.
• Access Criteria: Requests should be directed to the principal investigator. Proposals will be reviewed by the study steering committee and must state a methodologically sound scientific aim. Approved requesters will be required to sign a data access agreement, and the study protocol requires prior approval by the institutional research ethics committee (CAPPesq) before any transfer.

Locations

BR (1)