NCT07391033

Brief Summary

To compare the angiographic and clinical outcomes of aggressive versus standard balloon preparation during drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR). The study will evaluate whether more aggressive lesion preparation with cutting/scoring/OPN balloons improves outcomes compared to standard preparation with semi-compliant or non-compliant balloons.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Jun 2026

Status
not yet 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

First Submitted

Initial submission to the registry

January 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

January 29, 2026

Last Update Submit

January 29, 2026

Conditions

In-Stent Coronary Artery RestenosisCoronary Artery Disease

Keywords

Drug-Coated BalloonIn-Stent RestenosisLesion PreparationCutting BalloonScoring BalloonPercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiovascular Events (MACE)

    Composite of cardiac death, non-fatal myocardial infarction (MI), or target lesion revascularization (TLR).

    12 months

Secondary Outcomes (9)

  • Cardiac Death

    12 months and longest available follow-up

  • Non-fatal Myocardial Infarction

    12 months and longest available follow-up

  • Target Lesion Revascularization (TLR)

    12 months and longest available follow-up

  • Target Vessel Myocardial Infarction (TV-MI)

    12 months and longest available follow-up

  • BARC Major Bleeding

    12 months and longest available follow-up

  • +4 more secondary outcomes

Study Arms (2)

Aggressive Lesion Preparation

Patients who underwent lesion preparation using cutting/Wolverine balloons, scoring balloons (any brand), and/or OPN balloons prior to DCB angioplasty for ISR.

Standard Lesion Preparation

Patients who underwent lesion preparation using semi-compliant balloons and/or non-compliant balloons prior to DCB angioplasty for ISR.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who underwent drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR) at participating centers.

You may qualify if:

  • Adult patients ≥18 years of age
  • Patients who underwent DCB angioplasty for in-stent restenosis

You may not qualify if:

  • \- Lack of clinical outcome assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Wańha W, Iwańczyk S, Tajstra M, Cortese B. How to treat coronary in-stent restenosis? Recent advances and their practical implications: State-of-the-Art Review. Kardiol Pol. 2025;83(5):556-569. doi: 10.33963/v.phj.105954.

    BACKGROUND

  • Dangas GD, Claessen BE, Caixeta A, Sanidas EA, Mintz GS, Mehran R. In-stent restenosis in the drug-eluting stent era. J Am Coll Cardiol. 2010;56:1897-907. doi: 10.1016/j.jacc.2010.07.028.

    BACKGROUND

  • Latib A, Mussardo M, Ielasi A, Tarsia G, Godino C, Al-Lamee R, Chieffo A, Airoldi F, Carlino M, Montorfano M, Colombo A. Long-term outcomes after the percutaneous treatment of drug-eluting stent restenosis. JACC Cardiovasc Interv. 2011;4:155-64. doi: 10.1016/j.jcin.2010.09.027.

    BACKGROUND

  • Mauri L, Bonan R, Weiner BH, et al. Cutting balloon angioplasty for the prevention of restenosis: results of the Cutting Balloon Global Randomized Trial. Am J Cardiol. 2002;90(10):1079-1083. doi: 10.1016/S0002-9149(02)02773-X.

    BACKGROUND

  • Bonaventura K, Schwefer M, Yusof AKM, Waliszewski M, Krackhardt F, Steen P, Ocaranza R, Zuhdi AS, Bang LH, Graf K, Böck U, Chin K. Systematic Scoring Balloon Lesion Preparation for Drug-Coated Balloon Angioplasty in Clinical Routine: Results of the PASSWORD Observational Study. Adv Ther. 2020 May;37(5):2210-2223. doi: 10.1007/s12325-020-01320-2.

    BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Bharat Khialani, MD

    Tan Tock Seng Hospital, National Healthcare Group, Singapore

    PRINCIPAL INVESTIGATOR

  • Filippo Luca Gurgoglione, MD, PhD

    Department of Cardiology, Parma University Hospital, Parma, Italy

    PRINCIPAL INVESTIGATOR

  • Bernardo Cortese, MD

    Fondazione Ricerca e Innovazione Cardiovascolare ETS

    STUDY CHAIR

Central Study Contacts

Filippo Luca Gurgoglione, MD, PhD

CONTACT

+393312048150filippolucagurgoglione@gmail.com

Beatrice Barbano

CONTACT

segreteria@fondazioneric.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 5, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

February 5, 2026

Record last verified: 2026-01