AnGiographic Performance With A Sirolimus-elutiNG Balloon in the TrEatment of De Novo CoronaRy Artery Disease (GINGER)

February 21, 2024 updated by: Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

AnGiographic Performance Following PCI With A Sirolimus-elutiNG Balloon in the TrEatment of De Novo CoronaRy Artery Disease: GINGER Study

Evaluate angiographic performance in long lesions of Sirolimus Eluting Balloon Magic Touch by Concept Medical

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To assess the angiographic performance of the Magic Touch Sirolimus-Coated Balloon (SCB) at 9 months follow-up after PCI for de novo CAD.

Primary end-points:

  • Late lumen loss (LLL) at the SCB-treated segment within 9 months after the index procedure;
  • Mean net lumen diameter gain at the SCB-treated segment at 9 months angiographic follow-up.

Secondary end-points:

  • Procedural success defined as both SCB delivery and inflation at the "target" lesion site with <30% diameter stenosis (DS) in the SCB-treated segment and distal Thrombolysis In Myocardial Infarction (TIMI) 3 flow;
  • Peri-procedural myocardial infarction (PMI) defined according to the EXCEL trial (creatinine kinase myocardial band) or Society for Cardiovascular Angiography and Interventions definitions (troponin);
  • Binary restenosis rate at the SCB-treated segment at 9 months angiographic follow-up;
  • A Device Oriented Composite End-point (DOCE) and its singular components (cardiac death, any target-vessel myocardial infarction excluding PMI, ischemia-driven target lesion revascularization) in-hospital, within 7 days after PCI; phone follow-up at 30-day (+/- 7 days) and 12 months (+/- 1 month) and a follow-up visit at 9 months (+/- 1 month). Any definite/probable SCB-treated segment thrombosis (in-hospital, within 7 days after PCI and at 30-day, 9-month, 1-year follow-up).

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Italy/MI
      • Milan, Italy/MI, Italy, 20132
        • Active, not recruiting
        • IRCCS Ospedale San Raffaele
      • Milan, Italy/MI, Italy, 20138
      • Milan, Italy/MI, Italy, 20157
        • Recruiting
        • IRCCS Ospedale Galeazzi Sant'Ambrogio
        • Contact:
    • Italy/RM
      • Rome, Italy/RM, Italy, 00133
    • Italy/TV
      • Conegliano, Italy/TV, Italy, 31015
    • Italy/UD
      • Udine, Italy/UD, Italy, 33100
        • Active, not recruiting
        • Ospedale Santa Maria della Misericordia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Age >18 years
  2. Patients presenting with stable or unstable coronary artery disease (CAD) eligible for percutaneous coronary intervention (PCI) with de novo CAD in one or two separates major epicardial territories and at least one lesion suitable for sirolimus coated balloon (SCB);
  3. Reference vessel diameter (RVD) at the SCB target site ≥2.0 mm and ≤4.0 mm (by visual estimation and/or quantitative coronary angiography);
  4. Lesion length at the SCB target site ≥25 mm;
  5. Successful lesion preparation (full and homogenous pre-dilatation balloon expansion without type C-F dissection and/or TIMI flow=3 at the SCB target site;
  6. SCB-target lesion located in the same or other vessels treated by drug-eluting stent (DES) implantation;
  7. Patient able to understand and provide informed consent and comply with all study procedures including 9 months angiographic follow-up.

Exclusion criteria:

  1. Patients participating in another clinical evaluation;
  2. Age <18 years;
  3. Cardiogenic shock;
  4. Pregnancy or breastfeeding women; pregnancy test, either urine or blood test must be performed within 7 days prior to the index procedure in woman of child-bearing potential, and must not commit to initiating a pregnancy for 12 weeks after implantation, using effective contraception;
  5. Thrombus containing lesion;
  6. Unprotected left main as a target lesion unless this lesion is treated with a DES and SCB inflated distally or on a branch or on a different vessel;
  7. Comorbidities with life expectancy <6 months;
  8. Aorto-ostial target lesion (within 3 mm of the aorta junction); unless this lesion is treated with a DES and SCB inflated distally or on a branch or on a different vessel;
  9. Target lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft;
  10. Every known allergy, intolerance or hypersensitivity to any medication used during the procedure and to drugs recommended after the procedure (e.g. aspirin, clopidogrel, ticagrelor, prasugrel);
  11. Severe chronic kidney disease (glomerular filtration rate<30 ml/min/1.73 m2);
  12. Platelet count <50,000cells/mm;
  13. Stroke within the previous 6 months;
  14. RVD at the SCB target site <2.0 mm or >4.0 mm (by visual estimation and/or QCA); target lesion with RVD larger than 4 mm can be treated with a DES and SCB inflated in other segments of the same or other vessels.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: angiographic evaluation
QCA at 9 months
Device: Magic Touch SCB by Concept Medical Inc.
PCI with drug-coated balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
late lumen loss at 9 months measured by quantitative coronary angiography
Time Frame: 18 months
QCA by core lab
18 months
incidence of adverse clinical events
Time Frame: 18 months
myocardial infarction, death, need for revascularization
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

Investigators

  • Study Chair: Antonio Colombo, MD, Humanitas Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2023

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

July 20, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (Actual)

July 22, 2022

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GINGER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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