Bioresorbable ScaffoldsNCT02001025
Performance of Bioabsorbable Vascular Scaffolds (Absorb) Compared to Xience Stents - an Optical Coherence Tomography Study
An observational study of Bioresorbable Scaffolds, run by Rudolf Berger at 1 site in Austria.
Trial summary
The biodegradable ABSORB scaffold is characterized by a greater strut thickness, but it has a greater flexibility compared to the XIENCE stent. Due to its fragility the inflating pressure of the ABSORB scaffold is limited and suitable lesions have to be well prepared. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bioresorbable Scaffolds
- What is being tested?
- Absorb scaffold and Xience stent
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2013to Dec 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with coronary artery disease
Who may be able to join
- age < 55 years OR
- lesion length > 24mm OR
- multiple lesions to be treated
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, State of Vienna, 1090
Rudolf Berger, PD MD, +43 1 40400 4614, rudolf.berger@meduniwien.ac.at
Rudolf Berger, PD MD
About this study
The biodegradable ABSORB scaffold is characterized by a greater strut thickness, but it has a greater flexibility compared to the XIENCE stent. Due to its fragility the inflating pressure of the ABSORB scaffold is limited and suitable lesions have to be well prepared. This study assesses the incidence of malapposed stent-struts, and the frequency of stent-underexpansion and edge dissection after ABSORB implantation compared to the XIENCE stent.
- Conditions
- Bioresorbable Scaffolds
- Being tested
- Absorb scaffold, Xience stent
- Keywords
- coronary vessels, coronary stenosis, percutaneous transluminal angioplasty, stents, drug-eluting stents, bioresorbable scaffolds, optical coherence tomography
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorb scaffoldDevice
Xience stentDevice
| Study group | Role | What they receive |
|---|---|---|
| Absorb scaffold | Bioresorbable vascular scaffold implanted in coronary arteries, which are completely resorbed over a period of approximately two years Receives: Device: Absorb scaffold | |
| Xience stent | Second generation drug-eluting stent to treat coronary artery lesions Receives: Device: Xience stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse post-stenting results
Malapposition, underexpansion and edge dissections assessed with Optical Coherence Tomography (OCT)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioresorbable ScaffoldsStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rudolf Berger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rudolf Berger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001025
- Sponsor's protocol ID
- Absorb/Xience 01
- Status last verified
- Nov 2013
- First submitted
- 27 Nov 2013
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Bioabsorbable Vascular Scaffolds (Absorb) Compared to Xience Stents - an Optical Coherence Tomography Study
- ClinicalTrials.gov ID
- NCT02001025
- Acronym / sponsor ID
- Absorb/Xience 01
- Conditions
- Bioresorbable Scaffolds
- Keywords
- coronary vessels, coronary stenosis, percutaneous transluminal angioplasty, stents, drug-eluting stents, bioresorbable scaffolds, optical coherence tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rudolf BergerUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 4 Dec 2013 (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 biodegradable ABSORB scaffold is characterized by a greater strut thickness, but it has a greater flexibility compared to the XIENCE stent. Due to its fragility the inflating pressure of the ABSORB scaffold is limited and suitable lesions have to be well prepared. This study assesses the incidence of malapposed stent-struts, and the frequency of stent-underexpansion and edge dissection after ABSORB implantation compared to the XIENCE stent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorb scaffold | – | Device: Absorb scaffoldBioresorbable vascular scaffold implanted in coronary arteries, which are completely resorbed over a period of approximately two years |
| Xience stent | – | Device: Xience stentSecond generation drug-eluting stent to treat coronary artery lesions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with coronary artery disease
Key inclusion criteria (3 listed)
- age < 55 years OR
- lesion length > 24mm OR
- multiple lesions to be treated
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Absorb scaffold | Device | Absorb scaffold |
| Xience stent | Device | Xience stent |
Primary outcome
adverse post-stenting results
Time frame: 1 year
Malapposition, underexpansion and edge dissections assessed with Optical Coherence Tomography (OCT)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bioresorbable Scaffolds, run by Rudolf Berger at 1 site in Austria.
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 3 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Dalos, MD (+43 1 40400 4614, daniel.dalos@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse post-stenting results (time frame: 1 year). 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 4 Dec 2013.