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Stable AnginaPhase 4ALEX OCTNCT01637012

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

A Phase 4 study testing Implantation in people with Stable Angina and Unstable Angina, run by Balton Sp.zo.o. at 5 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Implantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
5 sitesPoland
Study dates
Feb 2012to Sep 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • Clinical Exclusion Criteria
  • anticipated inablility of the patient to comply with 12 months of antiplatelet treatment (e. g. elective non-cardiac surgery following stenting, drug intolerance etc.)
  • acute or chronic renal failure (serum creatinine > 2 mg%, GFR < 60 ml/min/1.73m2)
  • left ventricular ejection fraction (LVEF) < 40%
  • cardiogenic shock
  • short life expectancy (< 1 year)
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  • any significant medical condition which in the investigator's opinion may interference with the Patient's optimal participation in the study
  • current participation in another drug or device clinical trail in which there no be reached the primary endpoint or which clinically interferences with trail's enpoints
  • Angiographic Exclusion Criteria
  • chronic total occlusion
  • calcified lesion which cannot be successfully dilated
  • location of lesions in the winding vessels where there is no possibility of OCT imaging
  • target stenosis located in venous or arterial bridge
  • unprotected left main coronary disease with > 50% stenosis

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Poland5 sites

  • Polsko-Amerykanskie Kliniki Serca III Oddzial Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii

    Dąbrowa Górnicza, Szpitalna 13, 43-300

  • Carint Scanmed Szpital Sw. Rafala

    Krakow, Bochenka 12, 30-693

  • Szpital Uniwersytecki w Krakowie, Samodzielna Pracownia Zakladu Hemodynamiki i Angiografii

    Krakow, Kopernika 17, 31-501

  • Polsko-Amerykanskie Kliniki Serca I Oddzial Kardiologiczno-Angiologiczny

    Ustroń, Sanatoryjna 7, 43-450

  • Centralny Szpital Kliniczny MSWiA w Warszawie Klinika Kardiologii Inwazyjnej

    Warsaw, Woloska 137, 02-507

Other trials in Poland

About this study

Official title: 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.

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.

Read the 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.

Being tested
Implantation
Keywords
ALEX, coronary stent, cobalt-chromium, sirolimus, OCT
Medical subject headings
Angina, Stable, Angina, Unstable, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImplantationProcedure or surgery

    Also called ALEX Stent

    index angioplasty with ALEX stent implatation

Study groups in NCT01637012
Study groupRoleWhat they receive
ALEX stent armExperimentalimplantation of ALEX stent during index procedure
Receives: Procedure: Implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of stent strut coverage and parameters of restenosis

    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

    Measured: at 12 months follow-up

  2. Assessment of stent strut coverage and parameters of restenosis

    Assessment of stent strut coverage and parameters of restenosis in coronary angiography (QCA - Late Lumen Loss) and in OCT (percent of neointimal volume) 6 months follow-up after the baseline procedure in group of second 20 patients

    Measured: at 6 months follow-up

  3. Assessment of stent strut coverage and parameters of restenosis

    Assessment of stent strut coverage and parameters of restenosis in coronary angiography (QCA - Late Lumen Loss) and in OCT (percent of neointimal volume) at 3 months follow-up after the baseline procedure in group of third 20 patients

    Measured: at 3 months follow-up

Secondary outcomes (5)

  1. Procedural success

    Procedural success during baseline PCI assessed in coronary angiography (QCA)

    Measured: during index hospitalization

  2. Occurrence of stent thrombosis

    Occurrence of stent thrombosis at 30 days follow-up

    Measured: at 30 days follow-up

  3. Occurrence of stent thrombosis

    Occurrence of stent thrombosis at 12 months follow-up

    Measured: at 12 months follow-up

  4. Incidence of Major Adverse Cardiac Events

    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

    Measured: at 30 days follow-up

  5. Incidence of Major Adverse Cardiac Events

    Incidence of Major Adverse Cardiac Events (MACEs) at 12 months follow-up defined as death, myocardial infarction target lesion re-PTCA or target lesion bypass graft

    Measured: at 12 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2012 (estimated)
  2. Study startFeb 2012
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01637012
Sponsor's protocol ID
2.0, 2011-12-01
Acronym
ALEX OCT
Status last verified
Mar 2014
First submitted
6 Jul 2012
Last updated
13 Mar 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Implantation in people with Stable Angina and Unstable Angina, run by Balton Sp.zo.o. at 5 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of stent strut coverage and parameters of restenosis (time frame: at 12 months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01637012.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2014; AzTrials last refreshed its copy on 27 Oct 2026.

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