CADNCT02853994
Safety and Efficacy of the DEVOIR Sirolimus-Coated Coronary Balloon in the Real-world Clinical Practice
An observational study of CAD, run by MINVASYS.
Trial summary
The study is a prospective, non-randomized, multicenter, post-marketing surveillance study evaluating the CE-marked DEVOIR Sirolimus-Coated Coronary Balloon in 4 subgroups regarding device approved indications: In-stent restenosis lesions: either bare metal or drug eluting stent restenosis Bifurcation lesions (with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CAD
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 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 coronary artery diseases (in-stent restenosis, small vessel diseases, bifurcation lesions, de novo lesions)
Who may be able to join
- Patient is at least 18 years old
- Lesion lengths ranging from 8 to 38 mm and diameters ranging from 1.50 mm to 4.00 mm.
Who cannot join
- Patients with a hypersensitivity to Sirolimus drug or its structural activity related compounds.
- Patients with a known hypersensitivity to excipients with phospholipid or related origins.
- Patients whose diseased segment cannot be pre-dilated or prepared before drug coated balloon treatment.
- Severely calcified lesions requiring treatment of other type for e.g. Rotational Atherectomy (Rotablator)
- Patients judged to have lesion that prevents complete inflation of angioplasty balloon or proper placement of delivery catheter
- Patients who cannot receive recommended antiplatelet or anticoagulation therapy.
About this study
Official title: Assessment of Safety and Efficacy of the DEVOIR Sirolimus-Coated Balloon for the Treatment of Native Coronary Artery Lesions in the Real-world Clinical Practice
The study is a prospective, non-randomized, multicenter, post-marketing surveillance study evaluating the CE-marked DEVOIR Sirolimus-Coated Coronary Balloon in 4 subgroups regarding device approved indications:
- In-stent restenosis lesions: either bare metal or drug eluting stent restenosis
- Bifurcation lesions (with drug-eluting stent in main branch and drug-coated balloon in side branch): treatment of lesion of all Medina types except (0,0,1) in native coronary arteries
- Small vessels: treatment of lesions ≤2.75 mm
- BMS implantation followed by DCB inflation
- Conditions
- CAD
- Keywords
- DCB, DEB, Sirolimus, PCI, ISR, SVD, Restenosis, Bifurcation, CAD, Coronary artery
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Major Adverse Cardiac Events (MACE)
Measured: 12 months
Secondary outcomes (4)
Rate of Target Lesion Revascularization (TLR)
Measured: 12 months
Rate of Target Vessel Failure (TVF)
Measured: 12 months
Rate of Target Vessel Revascularization (TVR)
Measured: 12 months
Angiographic success
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CADStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MINVASYS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853994
- Sponsor's protocol ID
- P1601
- Status last verified
- Jul 2016
- First submitted
- 18 Jul 2016
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Efficacy of the DEVOIR Sirolimus-Coated Balloon for the Treatment of Native Coronary Artery Lesions in the Real-world Clinical Practice
- ClinicalTrials.gov ID
- NCT02853994
- Acronym / sponsor ID
- P1601
- Conditions
- CAD
- Keywords
- DCB, DEB, Sirolimus, PCI, ISR, SVD, Restenosis, Bifurcation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- MINVASYSIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 3 Aug 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 study is a prospective, non-randomized, multicenter, post-marketing surveillance study evaluating the CE-marked DEVOIR Sirolimus-Coated Coronary Balloon in 4 subgroups regarding device approved indications:
- In-stent restenosis lesions: either bare metal or drug eluting stent restenosis
- Bifurcation lesions (with drug-eluting stent in main branch and drug-coated balloon in side branch): treatment of lesion of all Medina types except (0,0,1) in native coronary arteries
- Small vessels: treatment of lesions ≤2.75 mm
- BMS implantation followed by DCB inflation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery diseases (in-stent restenosis, small vessel diseases, bifurcation lesions, de novo lesions)
Key inclusion criteria (2 listed)
- Patient is at least 18 years old
- Lesion lengths ranging from 8 to 38 mm and diameters ranging from 1.50 mm to 4.00 mm.
Key exclusion criteria (6 listed)
- Patients with a hypersensitivity to Sirolimus drug or its structural activity related compounds.
- Patients with a known hypersensitivity to excipients with phospholipid or related origins.
- Patients whose diseased segment cannot be pre-dilated or prepared before drug coated balloon treatment.
- Severely calcified lesions requiring treatment of other type for e.g. Rotational Atherectomy (Rotablator)
- Patients judged to have lesion that prevents complete inflation of angioplasty balloon or proper placement of delivery catheter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Major Adverse Cardiac Events (MACE)
Time frame: 12 months
4 secondary outcomes
Rate of Target Lesion Revascularization (TLR)
Time frame: 12 months
Rate of Target Vessel Failure (TVF)
Time frame: 12 months
Rate of Target Vessel Revascularization (TVR)
Time frame: 12 months
Angiographic success
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of CAD, run by MINVASYS.
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 2 inclusion and 6 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 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Rate of Major Adverse Cardiac Events (MACE) (time frame: 12 months). 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 3 Aug 2016.