NCT07794839

Brief Summary

Evaluation of the efficacy and clinical outcomes of drug-eluting balloon therapy in ticyaici coronary artery disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Jan 2026Apr 2027

Study Start

First participant enrolled

January 1, 2026

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 31, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

August 31, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 26, 2026

Last Update Submit

August 26, 2026

Conditions

Keywords

drug coated balloondrug eluting stent

Outcome Measures

Primary Outcomes (1)

  • target lesion failure

    composite endpoint of target lesion revascularization, target vessel myocardial infarction and cardiac death

    12 month

Study Arms (2)

drug coated balloon

lesions treated with drug coated balloon

Device: drug coated balloon

drug eluting stent

lesions treated with drug eluting stent

Device: drug eluting stent

Interventions

patients treated with drug coated balloon dilatation

drug coated balloon

patients treated with drug eluting stent implantation

drug eluting stent

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

coronary artery lesions treated with drug coated balloon dilatation or drug eluting stent implantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Center, Training and Research Hospital, Department of Cardiology

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Shin D, Singh M, Shlofmitz E, Scheller B, Latib A, Kandzari DE, Zaman A, Mylotte D, Dakroub A, Malik S, Sakai K, Jeremias A, Moses JW, Shlofmitz RA, Stone GW, Ali ZA. Paclitaxel-coated versus sirolimus-coated balloon angioplasty for coronary artery disease: A systematic review and meta-analysis. Catheter Cardiovasc Interv. 2024 Sep;104(3):425-436. doi: 10.1002/ccd.31154. Epub 2024 Jul 24.

  • 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.

  • Camaj A, Leone PP, Colombo A, Vinayak M, Stone GW, Mehran R, Dangas G, Kini A, Sharma SK. Drug-Coated Balloons for the Treatment of Coronary Artery Disease: A Review. JAMA Cardiol. 2025 Feb 1;10(2):189-198. doi: 10.1001/jamacardio.2024.4244.

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Central Study Contacts

SERKAN KAHRAMAN, PROF, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Profesor, MD

Study Record Dates

First Submitted

August 26, 2026

First Posted

August 31, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

August 31, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations