Coronary Artery Disease (CAD)
Conditions
Brief summary
The main objective of the SeQuent® Please Neo post market surveillance is to assess the clinical suitability of the combination of pre-dilatation using the NSE Alpha scoring balloon before the use of the paclitaxel-coated SeQuent® Please Neo in an 'all comer'/ 'real world' setting for the treatment of in-stent restenosis and de-novo lesions.
Detailed description
The aim of this post market surveillance is to document the safety and efficacy of the drug-coated balloon Sequent® Please Neo in combination with the NSE Alpha scoring balloon in the treatment of both in-stent restenosis and de-novo lesions in native coronary arteries with reference diameters of 2.5 mm up to 4.0 mm with lesion lengths of 30 mm for procedural success and preservation of vessel patency
Interventions
DEVICEDrug Coated Balloon Angioplasty, Scoring Balloon Dilatation
Percutaneous Coronary Intervention
Sponsors
Ernst von Bergmann Hospital
B. Braun Melsungen AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with in-stent restenosis and de-novo lesions in coronary arteries
Exclusion criteria
* Intolerance to paclitaxel and/or the balloon coating * Allergy to components of the balloon coating * Pregnancy and lactation * Complete occlusion of the treatment vessel * Severely calcified stenosis * Cardiogenic shock * Risk of an intraluminal thrombus * Haemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Failure | 9 months | Target Vessel Failure = TLR + Myocardial Infarction (MI) + cardiac death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| procedural success rate | intraprocedural | lesion crossing success in in-stent restenotic lesions |
| Target Lesion Revascularization rate = Re-PCI + CABG(TLR) | 9 months | — |
| cardiac death | 9 months | death of cardiac or unknown causes |
| Rate of coronary arterial bypass grafting (CABG) | 9 months | — |
| rate of myocardial infarction | 9 months | — |
Countries
Germany
Outcome results
None listed