BIOTRONIKS-Safety and Clinical Performance of the First Drug-Eluting Generation Absorbable Metal Stent In Patients with de Novo Lesions in Native Coronary Arteries (BIOSOLVE-I study)

Completed

• Conditions: coronary stenosis; narrowing of the vessels (arteries) which supply the heart with blood; 10011082

• Registration Number: NL-OMON56825
• Lead Sponsor: Biotronik AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Patient is between >/= 18 year and 2. Written patient informed consent available prior to PCI
3. Patients with stable or unstable angina pectoris or documented silent ischemia
4. Patient eligible for PCI
5. Patient acceptable candidate for coronary artery bypass surgery
6. Patients with a maximum of two lesions in two separate coronary arteries which have to be de novo lesions.
7. Target reference vessel diameter by visual estimation, assisted by QCA / IVUS: 3.0 - 3.5 mm
8. Target lesion length by visual estimation, assisted by QCA / IVUS: 9. Target lesion stenosis by visual estimation, assisted by QCA / IVUS: >/= 50% - < 100%

Exclusion Criteria

1. Left ventricular ejection fraction of < 30%
2. Patients with three-vessel where all three vessels require treatment
3. Myocardial infarction (STEMI/NSTEMI) within 4 weeks of the intended treatment. Determination of CKMB and/or troponin T or I is required.
Notes:
Laboratory assessments to be done within 24 hours prior to intervention.
Patients with CKMB and/or troponin T or I > 3 fold the upper limit of normal must not be included in the trial.
4. Patients with risk of either acetylsalicylic acid, clopidogrel or Prasugrel cessation
5. Impaired renal function (serum creatinine > 2.0mg/dl or 177 umol/l, determined within 72 hours prior to intervention)
6. Additional coronary lesions (restenotic or de novo) in the same vessel which requires treatment
7. Lesions located within arterial or venous graft
8. Ostial lesions

Study & Design

• Study Type: Interventional
• Study Design: Not specified