Clinical trial · Interventional
A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions
A ComparIson of Strategies to Prepare Severely Calcified Coronary Lesions - A Prospective Randomized Controlled Trial of Super High-Pressure NC PTCA Balloon Versus Scoring PTCA Balloon in Severely Calcified Coronary Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this prospective, multicenter, randomized, open-label trial is to evaluate the completeness of stent expansion following a strategy of lesion preparation with either a Super High-Pressure NC PTCA Balloon (OPN NC) or a Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty in an angiographically well-defined group of patients with severely calcified coronary lesions (grade 3) undergoing coronary stent implantation (SYNERGY everolimus-eluting stent (EES)).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Calcified Coronary Artery Disease (Grade 3) | Grade 3 Follicular Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Scoring PTCA Balloon (NSE Alpha) | Device | — | UNRESOLVED |
| Super High-Pressure NC PTCA Balloon (OPN NC) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- OPN NC
- description
- Patients receiving a Super High-Pressure NC PTCA Balloon (OPN NC)
- interventionNames
- Device: Super High-Pressure NC PTCA Balloon (OPN NC)
- type
- EXPERIMENTAL
- label
- NSE Alpha
- description
- Patients receiving a Scoring PTCA Balloon (NSE Alpha)
- interventionNames
- Device: Scoring PTCA Balloon (NSE Alpha)
Primary outcomes (1)
- measure
- Stent expansion index (SEI)
- timeFrame
- intraprocedural
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age above 18 years and consentable; * Persistent angina symptoms despite optimal medical therapy and/or evidence of inducible ischemia; * Angiographically-proven coronary artery disease; * De novo lesion in a native coronary artery; * Target reference vessel diameter between 2.25 and 4.00 mm by visual estimation; * Calcification of the target lesion as determined by angiography (grade 3); * Unsuccessful lesion preparation (\<30% reduction of baseline diameter stenosis) with conventional NC balloon angioplasty * Written informed consent. Exclusion Criteria: * Myocardial infarction (within 1 week); * Limited long-term prognosis due to other conditions; * Target lesion is in a coronary artery bypass graft; * Target lesion is an in-stent restenosis; * Target lesion is aorto-ostial; * Target vessel thrombus.
References
Publications (0)
Data not yet available