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)

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) - BIOSOLVE-I Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON56825

Enrollment

Registered

2010-08-02

Start date

2010-08-27

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary stenosis narrowing of the vessels (arteries) which supply the heart with blood

Interventions

Percutanous Coronary Intervention with stent placement

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patient is between >/= 18 year and /= 50% -

Exclusion criteria

Exclusion criteria: 1. Left ventricular ejection fraction of 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

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is MACE* at 6 month follow-up for cohort 1 and at 12 months follow-up for cohort 2. *composite of cardiac death, myocardial infarction, clinically driven target lesion revascularization	—

Secondary

Measure	Time frame
In-stent late lumen loss at 6 / 12 months (depending on patient cohort) In-segment late lumen loss at 6 / 12 months (depending on patient cohort) Percent in-stent diameter restenosis at 6 / 12 months (depending on patient cohort) Percent in-segment diameter restenosis at 6 / 12 months (depending on patient cohort) Binary in-stent restenosis at 6 / 12 months (depending on patient cohort) Binary in-segment restenosis at 6 / 12 months (depending on patient cohort) For both cohorts: Cumulative MACE* rate at 1, 6, 12, 24 and 36 months (*composite of cardiac death, myocardial infarction, clinically driven Target Lesion Revascularization) Stent thrombosis rate Device success Procedural success	—

Measure

Time frame

In-stent late lumen loss at 6 / 12 months (depending on patient cohort) In-segment late lumen loss at 6 / 12 months (depending on patient cohort) Percent in-stent diameter restenosis at 6 / 12 months (depending on patient cohort) Percent in-segment diameter restenosis at 6 / 12 months (depending on patient cohort) Binary in-stent restenosis at 6 / 12 months (depending on patient cohort) Binary in-segment restenosis at 6 / 12 months (depending on patient cohort) For both cohorts: Cumulative MACE* rate at 1, 6, 12, 24 and 36 months (*composite of cardiac death, myocardial infarction, clinically driven Target Lesion Revascularization) Stent thrombosis rate Device success Procedural success

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)