Stents vs Paclitaxel-Coated Balloons for Complex and Small Coronary Vessels

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study compares paclitaxel-coated balloons (DCB) with current drug-eluting stents (DES) for treating complex and small coronary lesions in patients with non-ST-elevation acute coronary syndrome or chronic coronary syndrome. It also directly compares two paclitaxel-coated balloons, Protégé and Agent, to see if one provides better outcomes. The rationale is to deliver anti-proliferative therapy without leaving a permanent implant in select lesions, potentially reducing restenosis, thrombosis, and need for repeat procedures. The trial includes adults with appropriate angiographic features and ischemia, and requires consent and feasibility for follow-up. Outcome measures likely include major adverse cardiovascular events and device-related safety, though design details are focused on device comparison rather than hard endpoints alone.

Why it matters

Who can join: the full rules

Clinical inclusion criteria:

1. Age≥18 years
2. Patient with NSTE-ACS or CCS with either symptoms and/or ischemia on non-invasive or invasive testing (i.e. FFR/iFR, CMR, SPECT, PET-CT or stress-echo)
3. The patient must be able to understand and provide written informed consent and comply with all study procedures
4. Life expectancy of \> 2 years

   Angiographic inclusion criteria:
5. One or more trial target vessel (LAD, CX or RCA, or of their branches) with:

   1. Stenosis of ≥70% or
   2. Stenosis ≥50% and \<70% (visually assessed) with evidence of ischemia by positive stress test, or FFR ≤0.80, or iFR \<0.90 or IVUS minimum lumen area ≤4.0 mm2
6. The target vessel/target lesion matches at least one of the following criteria

   1. Small vessel: vessel reference diameter is ≤ 3 mm
   2. Long lesions: length ≥ 25 mm
   3. Calcified lesion: grade 3 by angiography or confirmed on intravascular imaging
   4. Chronic total occlusion (CTO)
   5. Bifurcation lesions, including ostial LAD and ostial CX
   6. Lesions in diabetic coronary artery disease
   7. In-Stent Restenosis (ISR)
7. Lesion preparation must be according to the 3rd DCB consensus, with lesions that have:

   1. ≤ 30% residual stenosis
   2. TIMI (Thrombolysis in Myocardial Infarction) flow grade 3.
   3. The absence of flow-limiting dissection (Type A-C allowed only)

Clinical exclusion criteria:

1. STEMI or cardiogenic shock related to an acute MI within 2 days prior to the index PCI
2. Pregnancy or nursing declarations (As per country specific guideline) (a negative pregnancy test is required of women with child-bearing potential within 7 days prior to enrollment)
3. LVEF\<30%
4. Known contraindication or hypersensitivity to any limus family drugs, paclitaxel, or to medications such as heparin, aspirin, clopidogrel, ticlopidine, prasugrel and ticagrelor or any component of the devices.
5. Allergy to imaging contrast media which cannot be adequately pre-medicated
6. Stroke/TIA during the last 6 months, or any prior intracranial hemorrhage
7. Active peptic ulcer or upper gastrointestinal bleeding within last 6 months
8. Known renal insufficiency with an eGFR\<30 ml/min1.73m2, or subject on dialysis, or acute renal failure (as per physician judgment)
9. Planned surgery within 6 months with the necessity to stop DAPT
10. History of bleeding diathesis or coagulopathy
11. Platelet count\<100.000 cells/mm3 or \>400.000 cells/mm3, a WBC of \<3000 cells/mm3, documented or suspected liver disease (including laboratory evidence of hepatitis)
12. Patient is a recipient of a heart transplant
13. Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation

    Angiographic exclusion criteria:
14. Target lesion is in the left main coronary artery
15. Target lesion is in a coronary artery bypass graft
16. Flow limiting target vessel thrombus
17. Evidence of aneurysm in target vessel within 10 mm of the target lesion
18. Aorto-ostial target lesion (within 3 mm of the aorta junction)

Where it's running

• Luzerner Kantonsspital Spitalstrasse, 6000 Luzern 16, Switzerland
  Lucerne, Canton of Lucerne, Switzerland Recruiting

Study contacts

• Principal investigator: Prof. Dr. Florim Cuculi, MD — Cardiology Division Heart Center - Luzerner Kantonsspital Spitalstrasse, 6000 Luzern 16, Switzerland
• Study coordinator: Dr Brijesh Mishra, PhD
• Email: drbrijeshmishra@translumina.in
• Phone: +919654596737

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating the OSFIT drug-eluting stent for coronary artery stenosis

  This study is testing whether the OSFIT drug-eluting stent is safe and effective for people with narrowed coronary arteries near the heart's main opening, following them for a year after their procedure.

  Recruiting Genoss Co., Ltd. · Suwon · NCT06066450

• 24-month versus 12-month dual antiplatelet therapy after drug-eluting stent in people with high Lipoprotein(a)

  This trial will test whether continuing dual antiplatelet therapy for 24 months instead of 12 months lowers the risk of death, heart attack, or stroke in people with high Lipoprotein(a) who had a drug-eluting stent and were event-free at one year.

  Recruiting China National Center for Cardiovascular Diseases · Beijing, Beijing Municipality · NCT06014060

• μFR-guided Drug-Coated Balloon Angioplasty vs Angiography-guided Angioplasty in Coronary Artery Disease

  This trial tests whether using computational μFR guidance during drug-coated balloon angioplasty is better than standard angiography guidance for people with de novo coronary artery lesions.

  Recruiting Centro Cardiologico Monzino · Cosenza, CS and 3 other locations · NCT07917234

• Gastric Ultrasound Before CABG to See if Heart Function Changes Stomach Contents

  This study checks whether people with weaker heart function before elective CABG have different stomach contents seen on ultrasound.

  Recruiting Adiyaman University · Adıyaman · NCT07898215

• Can preoperative photon-counting CT help predict heart recovery after bypass surgery?

  This observational study tests whether a preoperative photon-counting CT can help predict heart function 3 months after coronary bypass surgery in adults with coronary artery disease.

  Recruiting Chinese PLA General Hospital · Beijing · NCT07883499

• Real-World Drug-Coated Balloon Angioplasty in Coronary Artery Disease

  This registry tests how drug-coated balloons perform in everyday clinical practice for adults with coronary artery disease undergoing PCI.

  Recruiting at 5 sites Hospital Arnau de Vilanova · Mexico City, Mexico City and 4 other locations · NCT07875088

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.