AnginaFEASTRUNCT02707783
Feasibility and Outcomes of Complete Coronary Revascularization Using BVS in All-comer Patients With Angina
An observational study of Angina, run by International Foundation for Development of Medical Science and Education Healthy Heart at 14 sites in Russia.
Trial summary
The aim of the study is feasibility of complete coronary revascularization with bioresorbable vascular scaffold (BVS) implantation and assessment of treatment outcomes in a group of consecutive patients with stable and unstable angina in Russian population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina
- What is being tested?
- Bioresorbable vascular scaffold (BVS) implantation
- Type of treatment
- Medical device
- How many people
- 1,602 participants
- Where
- 14 sitesRussia
- Study dates
- Nov 2015to Jul 2018
- Phase
- Observational
- 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
Study population: Patients with stable and unstable angina qualified for revascularization (PCI or CABG) after coronary angiography.
Who may be able to join
- Patient characteristics
- Age > 18 years
- Able and willing to give informed consent
- Willing to comply with specified follow-up evaluations
- Clinical manifestation of coronary artery disease: stable angina or unstable angina
- Indications for coronary revascularization
Who cannot join
- Patient characteristics
- Acute Myocardial infarction
- Cardiogenic shock
- Any reason for patient's inability to comply with 12-month double antiplatelet therapy (DAPT)
- Absolute contraindications to DES or BVS implantation
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Russia14 sites
Federal Center for Cardiovascular Surgery
Chelyabinsk, Av. Hero of Russia 2 Rodionov E.N., 454003
Federal Cardiovascular Center
Kaliningrad, 238 312
Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases
Kemerovo, 650002
Regional Clinical Hospital n.a. S.V.
Krasnodar, Ochapovskogo, 350 086
Federal Cardiovascular Center
Krasnoyarsk, Karaulnaya 45
Regional Clinical Hospital
Krasnoyarsk
Regional Hospital
Magadan, Nagaevskaya 40, 685 000
Clinical Hospital No 1 of Department of Presidents Affairs
Moscow, 121352
President's Hospital with Policlinic
Moscow, 121359
Central Railway Hospital 2
Moscow, 129128
CELT Hospital
Moscow
City Clinical Hospital named S.S.Yudina Department of Health of the City of Moscow
Moscow
Federal Cardiovascular Center
Perm, 614 013
Tyumen Cardiology Center
Tyumen
About this study
Official title: Feasibility and Outcomes of Complete Coronary Revascularization Using Bioresorbable Vascular Scaffold in All-comer Patients With Stable and Unstable Angina: A Multi-centre Registry in Russian Population
The aim of the study is feasibility of complete coronary revascularization with bioresorbable vascular scaffold (BVS) implantation and assessment of treatment outcomes in a group of consecutive patients with stable and unstable angina in Russian population.
The hypothesis of this registry study: 1) Complete coronary revascularization with BVS implantation will be feasible to perform in at least 70 percent of patient population with stable and unstable angina qualified for revascularization after coronary angiography, 2) Complete revascularization with BVS is as safe and effective as revascularization with standard BMS (Bare Metal Stent BMS/ Drug Eluting Stent DES stent implantation (published literature comparators in matched populations).
Up to 2500 patients will be enrolled in 13 Russian high volume invasive cardiology centres. 12 month clinical observation and 5-year clinical follow-up is expected.
Read the detailed description
Study design: Data regarding all consecutive patients qualified for revascularization (PCI Percutaneous Coronary Intervention or CABG Coronary Artery Bypass Grafting) will be collected in this prospective study. Information regarding revascularization strategy will be collected as detailed information concerning PCI procedure. In case of PCI with other than BVS stent implantation (BMS or/and metallic DES) information collected in the study will contain at least:
- Reason why BVS was not implanted
- Final result of baseline treatment
- Acute and long-term outcome of treatment (12 month clinical observation); NB. 5-year clinical follow-up is also expected.
The enrollment phase of the registry is not expected to last longer than 12 months.
- Conditions
- Angina
- Being tested
- Bioresorbable vascular scaffold (BVS) implantation
- Keywords
- stable and unstable angina, bioresorbable vascular scaffold, BVS, PCI
- Medical subject headings
- Angina Pectoris, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioresorbable vascular scaffold (BVS) implantationDevice
| Study group | Role | What they receive |
|---|---|---|
| Bioresorbable vascular scaffold (BVS) implantation | Patients with un/stable angina that require coronary revascularization undergoing the BVS implantation Receives: Device: Bioresorbable vascular scaffold (BVS) implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic endpoints: assessment of stent implantation final result:stent delivery, technical success (yes/no)
Measured: periprocedural
Angiographic endpoints: assessment of stent implantation final result: percentage of residual stenosis (%)
Measured: periprocedural
Angiographic endpoints: assessment of stent implantation final result: dissection (yes/no)
Measured: periprocedural
Angiographic endpoints: assessment of stent implantation final result: slow-flow (yes/no)
Measured: periprocedural
Angiographic endpoints: assessment of stent implantation final result: no-flow (yes/no)
Measured: periprocedural
Angiographic endpoints: assessment of stent implantation final result: distal embolization (yes/no)
Measured: periprocedural
Angiographic endpoints: assessment of stent implantation final result: side-branch occlusion (yes/no)
Measured: periprocedural
Angiographic endpoints: assessment of stent implantation final result: coronary artery perforation (yes/no)
Measured: periprocedural
Acute gain (mm)
Measured: periprocedural
Major Adverse Cardiovascular Events
Measured: From hospital discharge till 12 months follow up
Major Adverse Cardiovascular Events
Measured: in 12 month follow up
TVF (Target Vessel Failure)
Measured: in 12 month follow-up
Any revascularization
Numbers of any revascularization per patient.
Measured: in 12 month follow-up
Stent thrombosis (possible and probable)
Measured: in 12 month follow-up
Periprocedural MI (Myocardial Infarction) (yes/no)
Measured: periprocedural
Angina assessment questionnaire
Measured: 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionJun 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,602 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Foundation for Development of Medical Science and Education Healthy Heart
- Sponsor type
- University, hospital or other
- Collaborators
- KCRI
- Responsible party
- Sponsor
- Investigators
- Piotr Musiałek, MD DPhil, Study chair, John Paul II Hospital in Krakow, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707783
- Sponsor's protocol ID
- FEAST.RU
- Acronym
- FEASTRU
- Status last verified
- Aug 2018
- First submitted
- 18 Feb 2016
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Outcomes of Complete Coronary Revascularization Using Bioresorbable Vascular Scaffold in All-comer Patients With Stable and Unstable Angina: A Multi-centre Registry in Russian Population
- ClinicalTrials.gov ID
- NCT02707783
- Acronym / sponsor ID
- FEASTRU / FEAST.RU
- Conditions
- Angina
- Keywords
- stable and unstable angina, bioresorbable vascular scaffold, BVS, PCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,602 participants (actual)
- Lead sponsor
- International Foundation for Development of Medical Science and Education Healthy HeartUniversity, hospital or other
- Collaborators
- KCRI
- Study start
- Nov 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is feasibility of complete coronary revascularization with bioresorbable vascular scaffold (BVS) implantation and assessment of treatment outcomes in a group of consecutive patients with stable and unstable angina in Russian population.
The hypothesis of this registry study: 1) Complete coronary revascularization with BVS implantation will be feasible to perform in at least 70 percent of patient population with stable and unstable angina qualified for revascularization after coronary angiography, 2) Complete revascularization with BVS is as safe and effective as revascularization with standard BMS (Bare Metal Stent BMS/ Drug Eluting Stent DES stent implantation (published literature comparators in matched populations).
Up to 2500 patients will be enrolled in 13 Russian high volume invasive cardiology centres. 12 month clinical observation and 5-year clinical follow-up is expected.
Detailed description
Study design: Data regarding all consecutive patients qualified for revascularization (PCI Percutaneous Coronary Intervention or CABG Coronary Artery Bypass Grafting) will be collected in this prospective study. Information regarding revascularization strategy will be collected as detailed information concerning PCI procedure. In case of PCI with other than BVS stent implantation (BMS or/and metallic DES) information collected in the study will contain at least:
- Reason why BVS was not implanted
- Final result of baseline treatment
- Acute and long-term outcome of treatment (12 month clinical observation); NB. 5-year clinical follow-up is also expected.
The enrollment phase of the registry is not expected to last longer than 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bioresorbable vascular scaffold (BVS) implantation | – | Device: Bioresorbable vascular scaffold (BVS) implantationPatients with un/stable angina that require coronary revascularization undergoing the BVS implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stable and unstable angina qualified for revascularization (PCI or CABG) after coronary angiography.
Key inclusion criteria (6 listed)
- Patient characteristics
- Age > 18 years
- Able and willing to give informed consent
- Willing to comply with specified follow-up evaluations
- Clinical manifestation of coronary artery disease: stable angina or unstable angina
Key exclusion criteria (5 listed)
- Patient characteristics
- Acute Myocardial infarction
- Cardiogenic shock
- Any reason for patient's inability to comply with 12-month double antiplatelet therapy (DAPT)
- Absolute contraindications to DES or BVS implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioresorbable vascular scaffold (BVS) implantation | Device | Bioresorbable vascular scaffold (BVS) implantation |
Primary outcome
Angiographic endpoints: assessment of stent implantation final result:stent delivery, technical success (yes/no)
Time frame: periprocedural
Angiographic endpoints: assessment of stent implantation final result: percentage of residual stenosis (%)
Time frame: periprocedural
Angiographic endpoints: assessment of stent implantation final result: dissection (yes/no)
Time frame: periprocedural
Angiographic endpoints: assessment of stent implantation final result: slow-flow (yes/no)
Time frame: periprocedural
Angiographic endpoints: assessment of stent implantation final result: no-flow (yes/no)
Time frame: periprocedural
Angiographic endpoints: assessment of stent implantation final result: distal embolization (yes/no)
Time frame: periprocedural
Angiographic endpoints: assessment of stent implantation final result: side-branch occlusion (yes/no)
Time frame: periprocedural
Angiographic endpoints: assessment of stent implantation final result: coronary artery perforation (yes/no)
Time frame: periprocedural
Acute gain (mm)
Time frame: periprocedural
Major Adverse Cardiovascular Events
Time frame: From hospital discharge till 12 months follow up
Major Adverse Cardiovascular Events
Time frame: in 12 month follow up
TVF (Target Vessel Failure)
Time frame: in 12 month follow-up
Any revascularization
Time frame: in 12 month follow-up
Numbers of any revascularization per patient.
Stent thrombosis (possible and probable)
Time frame: in 12 month follow-up
Periprocedural MI (Myocardial Infarction) (yes/no)
Time frame: periprocedural
Angina assessment questionnaire
Time frame: 12 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Musiałek, MD DPhil study chair
John Paul II Hospital in Krakow, Poland
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angina, run by International Foundation for Development of Medical Science and Education Healthy Heart at 14 sites in Russia.
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 6 inclusion and 5 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 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Russia. 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.
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?
Angiographic endpoints: assessment of stent implantation final result:stent delivery, technical success (yes/no) (time frame: periprocedural). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2018.