Drug-coated Balloons Versus Drug-eluting Stents for de Novo Small-vessel Coronary Artery Disease

NCT07839806 | Active Not Recruiting FDA Device

• 1 other identifier: 17650/02102024
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, multicenter observational study will compare the safety and clinical outcomes of drug-coated balloon angioplasty and second-generation drug-eluting stent implantation in patients undergoing percutaneous coronary intervention for previously untreated lesions in small coronary vessels. The treatment strategy will be selected by the treating interventional cardiologist according to the patient's clinical and angiographic characteristics and will not be assigned randomly by the study. Participants will receive standard clinical care and will be followed for 12 months. The study will evaluate major adverse cardiovascular events, including cardiovascular death, myocardial infarction, and the need for repeat treatment of the target lesion. Procedural outcomes and treatment-related complications will also be recorded.

Conditions

Coronary Artery Disease

Keywords

Small vessel coronary artery disease; Coronary artery disease; Drug coated balloon; Drug eluting stent; Percutaneous Coronary Intervention; De Novo Coronary lesion

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events

  Number of participants experiencing at least one major adverse cardiovascular event, defined as the composite of cardiovascular death, nonfatal myocardial infarction, or clinically driven target lesion revascularization.

  From the index procedure through 12 months

Secondary Outcomes (6)

• Cardiovascular Death

  Through 12 months

• Nonfatal Myocardial Infarction

  Through 12 months

• Target Vessel Revascularization

  Through 12 months

• Procedural Success

  During the index procedure

• Major Bleeding

  During hospitalization and through 12 months

Study Arms (2)

Drug Coated Balloon Group

Patients undergoing percutaneous coronary intervention for de novo small-vessel coronary artery disease using a drug-coated balloon after adequate lesion preparation. Treatment selection is made by the treating interventional cardiologist as part of routine clinical care.

Device: Drug coated balloon

Drug Eluting Stent Group

Patients undergoing percutaneous coronary intervention for de novo small-vessel coronary artery disease using a second-generation drug-eluting stent. Treatment selection is made by the treating interventional cardiologist as part of routine clinical care.

Device: Drug Eluting stent

Interventions

Drug coated balloon DEVICE

Percutaneous coronary intervention performed using a drug-coated balloon following adequate lesion preparation. Balloon type, diameter, length, inflation pressure, and inflation duration are selected by the treating interventional cardiologist according to lesion characteristics and routine clinical practice. Bailout stent implantation may be performed when clinically required, including in cases of significant residual stenosis, impaired coronary flow, or flow-limiting dissection.

Drug Coated Balloon Group

Drug Eluting stent DEVICE

Percutaneous coronary intervention performed using a second-generation drug-eluting stent following lesion preparation. Stent type, diameter, length, implantation pressure, and post-dilatation strategy are selected by the treating interventional cardiologist according to lesion characteristics and routine clinical practice.

Drug Eluting Stent Group

Eligibility Criteria

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

Study Population

Consecutive adult patients with chronic coronary syndrome or non-ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention for de novo small-vessel coronary artery disease at participating centers will be considered for inclusion. Eligible lesions will be located in native coronary arteries with a reference vessel diameter greater than 2.0 mm and less than 2.75 mm. Patients will be included in the drug-coated balloon or second-generation drug-eluting stent cohort according to the treatment selected by the treating interventional cardiologist during routine clinical care. Treatment allocation will not be randomized or determined by the study protocol.

You may qualify if:

• Age 18 years or older. Chronic coronary syndrome or non-ST-elevation acute coronary syndrome requiring percutaneous coronary intervention.
• De novo lesion in a native coronary artery. Reference vessel diameter greater than 2.0 mm and less than 2.75 mm. Angiographic diameter stenosis greater than 70%. Successful lesion preparation, defined as residual stenosis of 30% or less, TIMI grade 3 flow, and absence of an NHLBI type C-F flow-limiting dissection.
• Treatment with a drug-coated balloon or a second-generation drug-eluting stent, selected at the discretion of the treating interventional cardiologist.
• Ability to provide informed consent and comply with clinical follow-up.

You may not qualify if:

• ST-elevation myocardial infarction requiring primary percutaneous coronary intervention.
• In-stent restenosis. Cardiogenic shock or hemodynamic instability at the time of the index procedure.
• Contraindication to antiplatelet therapy or to any component of the devices used.
• Life expectancy of less than 12 months because of a non-cardiovascular condition.
• Pregnancy. Inability to provide informed consent or complete the planned follow-up.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Sismanoglio General Hospital: collaborator

Study Sites (1)

First Department of Cardiology, Medical School of Athens, National and Kapodistrian University of Athens, General Hospital of Athens Ippokrateio, Athens, Greece

Athens, Attica, 11527, Greece

Location

Related Publications (5)

• 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. EuroIntervention. 2025 Apr 24;21(19):e1116-36. doi: 10.4244/EIJ-E-25-00021. Online ahead of print.

  PMID: 40272160 BACKGROUND

• Fezzi S, Serruys PW, Cortese B, Scheller B, Alfonso F, Jeger R, Colombo A, Joner M, Shin ES, Kleber F, 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 D, Krucoff M, Stone GW, Garg S, Onuma Y. Indications for Use of Drug-Coated Balloons in Coronary Intervention: Academic Research Consortium Position Statement. J Am Coll Cardiol. 2025 Oct 14;86(15):1170-1202. doi: 10.1016/j.jacc.2025.07.049.

  PMID: 41062231 BACKGROUND

• Fahrni G, Scheller B, Coslovsky M, Gilgen N, Farah A, Ohlow MA, Mangner N, Weilenmann D, Wohrle J, Cuculi F, Leibundgut G, Mobius-Winkler S, Zweiker R, Twerenbold R, Kaiser C, Jeger R; BASKET-SMALL 2 Investigators. Drug-coated balloon versus drug-eluting stent in small coronary artery lesions: angiographic analysis from the BASKET-SMALL 2 trial. Clin Res Cardiol. 2020 Sep;109(9):1114-1124. doi: 10.1007/s00392-020-01603-2. Epub 2020 Jan 29.

  PMID: 31993736 BACKGROUND

• Cortese B, Testa G, Rivero F, Erriquez A, Alfonso F. Long-Term Outcome of Drug-Coated Balloon vs Drug-Eluting Stent for Small Coronary Vessels: PICCOLETO-II 3-Year Follow-Up. JACC Cardiovasc Interv. 2023 May 8;16(9):1054-1061. doi: 10.1016/j.jcin.2023.02.011. Epub 2023 Apr 19.

  PMID: 37164603 BACKGROUND

• Tsiamis N, Tsakirian F, Papanikolaou A, Afendoulis D, Toulgaridis F, Dimitriadis K, Tolis I, Tzortzis S, Triantis G, Aghayan S, Tsioufis K, Toutouzas K. Revolutionizing Modern Percutaneous Coronary Intervention: Drug-Coated Balloons for Diabetics With Small Vessel Disease. A Narrative Review. Catheter Cardiovasc Interv. 2026 May;107(6):1922-1933. doi: 10.1002/ccd.70550. Epub 2026 Mar 15.

  PMID: 41833545 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Resident and PhD Candidate

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 24, 2026
• Study Start: October 3, 2024
• Primary Completion (Estimated): December 3, 2026
• Study Completion (Estimated): October 3, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)