Prospective, Single-arm, Multicenter Study for Evaluation the Safety and Effectiveness of the ALEX Stent in a Real-world Setting of Percutaneous Coronary Interventions in Patients With Coronary Heart Disease

Prospective, Single-arm, Multicenter Study for Evaluation the Safety and Effectiveness of the ALEX Stent in a Real-world Setting of Percutaneous Coronary Interventions in Patients With Coronary Heart Disease. Study With Angiography and OCT Follow-up.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01637012

Acronym

ALEX OCT

Enrollment

Registered

2012-07-10

Start date

2012-02-29

Completion date

2013-09-30

Last updated

2014-03-13

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

Conditions

Myocardial Infarction, Stable Angina, Unstable Angina

Keywords

ALEX, coronary stent, cobalt-chromium, sirolimus, OCT

Brief summary

To evaluate the safety and effectiveness of the ALEX stent in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.

Detailed description

Prospective, multicenter, non-randomized study designed to enroll up to 60 subjects to evaluate the safety and effectiveness of the cobalt-chromium sirolimus eluting coronary stent ALEX in a real-world setting of percutaneous coronary interventions in patients with coronary heart disease.

Interventions

PROCEDUREImplantation

index angioplasty with ALEX stent implatation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Clinical Inclusion Criteria: * \> 18 years of age * Patient must provide written informed consent prior to procedure using a form that is approved by the local Ethics Committee * clinical diagnosis of Stable Angina, Unstable Angina or Myocardial Infarction without ST elevation (NSTEMI) or Myocardial Infarction with ST elevation provided the expiry of 72 hours of the onset of symptoms and stable clinical and hemodynamical condition the Patient with patent postinfarcion artery (TIMI 3) and indications for PCI and next stage of revascularization in the other vessels * earlier effective supply of others lesions in others vessels in case of multivessels disease * female of childbearing potential must have a negative pregnancy test within 7 days prior to enrolment and utilize reliable birth control for 12 months after enrolment Angiographic Inclusion Criteria * target lesion stentosis must be \> 70% (visual estimate) * Patient eligible for PCI treatment with the ALEX stent system (vessel diameter in range of 2.5 to 4.0 mm and length of lesion that allows to cover a single stent with maximum length of 30 mm in visual evaluation)

Exclusion criteria

Clinical

Design outcomes

Primary

Measure	Time frame	Description
Assessment of stent strut coverage and parameters of restenosis	at 12 months follow-up	Assessment of stent strut coverage and parameters of restenosis in coronary angiography (QCA - Late Lumen Loss) and in OCT (percent of neointimal volume) 12 months follow-up after the baseline procedure in group of first 20 patients

Secondary

Measure	Time frame	Description
Procedural success	during index hospitalization	Procedural success during baseline PCI assessed in coronary angiography (QCA)
Occurrence of stent thrombosis	at 30 days follow-up	Occurrence of stent thrombosis at 30 days follow-up
Incidence of Major Adverse Cardiac Events	at 30 days follow-up	Incidence of Major Adverse Cardiac Events (MACEs) at 30 days follow-up defined as death, myocardial infarction target lesion re-PTCA or target lesion bypass graft

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026