Calcified Coronary Artery Disease (Grade 3)ISAR-CALCNCT03487432
A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions
A study testing Super High-Pressure NC PTCA Balloon (OPN NC) and Scoring PTCA Balloon (NSE Alpha) in people with Calcified Coronary Artery Disease (Grade 3), run by Deutsches Herzzentrum Muenchen at 5 sites in 2 countries.
Trial summary
The objective of this prospective, multicenter, randomized, open-label trial is to evaluate the completeness of stent expansion following a strategy of lesion preparation with either a Super High-Pressure NC PTCA Balloon (OPN NC) or a Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcified Coronary Artery Disease (Grade 3)
- What is being tested?
- Super High-Pressure NC PTCA Balloon (OPN NC) and Scoring PTCA Balloon (NSE Alpha)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 20 Jul 2018to 23 Oct 2019
- Phase
- Interventional
- 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
- Age above 18 years and consentable;
- Persistent angina symptoms despite optimal medical therapy and/or evidence of inducible ischemia;
- Angiographically-proven coronary artery disease;
- De novo lesion in a native coronary artery;
- Target reference vessel diameter between 2.25 and 4.00 mm by visual estimation;
- Calcification of the target lesion as determined by angiography (grade 3);
- Unsuccessful lesion preparation (<30% reduction of baseline diameter stenosis) with conventional NC balloon angioplasty
- Written informed consent.
Who cannot join
- Myocardial infarction (within 1 week);
- Limited long-term prognosis due to other conditions;
- Target lesion is in a coronary artery bypass graft;
- Target lesion is an in-stent restenosis;
- Target lesion is aorto-ostial;
- Target vessel thrombus.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen
Segeberger Kliniken GmbH
Bad Segeberg
Herzzentrum Leipzig
Leipzig
Deutsches Herzzentrum Muenchen
München
About this study
Official title: A ComparIson of Strategies to Prepare Severely Calcified Coronary Lesions - A Prospective Randomized Controlled Trial of Super High-Pressure NC PTCA Balloon Versus Scoring PTCA Balloon in Severely Calcified Coronary Lesions
The objective of this prospective, multicenter, randomized, open-label trial is to evaluate the completeness of stent expansion following a strategy of lesion preparation with either a Super High-Pressure NC PTCA Balloon (OPN NC) or a Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty in an angiographically well-defined group of patients with severely calcified coronary lesions (grade 3) undergoing coronary stent implantation (SYNERGY everolimus-eluting stent (EES)).
- Being tested
- Super High-Pressure NC PTCA Balloon (OPN NC), Scoring PTCA Balloon (NSE Alpha)
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super High-Pressure NC PTCA Balloon (OPN NC)Device
Strategy of Super High-Pressure NC PTCA Balloon (OPN NC) after unsuccessful lesion preparation with conventional NC balloon angioplasty.
Scoring PTCA Balloon (NSE Alpha)Device
Strategy of Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty.
| Study group | Role | What they receive |
|---|---|---|
| OPN NC | Experimental | Patients receiving a Super High-Pressure NC PTCA Balloon (OPN NC) Receives: Device: Super High-Pressure NC PTCA Balloon (OPN NC) |
| NSE Alpha | Experimental | Patients receiving a Scoring PTCA Balloon (NSE Alpha) Receives: Device: Scoring PTCA Balloon (NSE Alpha) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent expansion index (SEI)
Stent expansion index (SEI), defined as minimum stent area divided by mean reference area in an optical coherence tomography (OCT) quantitative analysis
Measured: intraprocedural
Secondary outcomes (8)
Angiographic Success
'Angiographic Success', defined as the achievement of residual angiographic stenosis <30% of the target lesion in the presence of TIMI 3 flow
Measured: intraprocedural
Procedural Success
'Procedural Success', defined as the achievement of angiographic success without any MACE, defined as cardiac death, target vessel related myocardial infarction and repeat revascularization (PTCA/PCI or coronary artery bypass graft [CABG])
Measured: 30 days
Strategy Success
'Strategy Success' defined as procedural success using the assigned study device and stent, without requirement for lesion preparations with further devices (i.e. rotational atherectomy [RA])
Measured: intraprocedural
Acute lumen gain,
Acute lumen gain, defined as minimal lumen diameter (MLD) post balloon angioplasty minus baseline MLD (mm)
Measured: intraprocedural
Complementary lesion preparations
Number of complementary lesion preparations with further devices (i.e. rotational atherectomy [RA])
Measured: intraprocedural
Rate of vessel perforation
Rate of vessel perforation
Measured: intraprocedural
Procedure duration
Procedure duration in min
Measured: intraprocedural
Contrast volume
Contrast volume in mL
Measured: intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start20 Jul 2018
- Primary completion23 Sep 2019
- Study completion23 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcified Coronary Artery Disease (Grade 3)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- SIS Medical AG
- Responsible party
- Sponsor
- Investigators
- Robert A Byrne, MD BCh PhD, Study chair, Deutsches Herzzentrum MuenchenSalvatore Cassese, MD PhD, Principal investigator, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03487432
- Sponsor's protocol ID
- GE IDE Nr. BA00117
- Acronym
- ISAR-CALC
- Status last verified
- Nov 2019
- First submitted
- 23 Mar 2018
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A ComparIson of Strategies to Prepare Severely Calcified Coronary Lesions - A Prospective Randomized Controlled Trial of Super High-Pressure NC PTCA Balloon Versus Scoring PTCA Balloon in Severely Calcified Coronary Lesions
- ClinicalTrials.gov ID
- NCT03487432
- Acronym / sponsor ID
- ISAR-CALC / GE IDE Nr. BA00117
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- SIS Medical AG
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 23 Oct 2019 (actual)
- First posted
- 4 Apr 2018 (actual)
- 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 objective of this prospective, multicenter, randomized, open-label trial is to evaluate the completeness of stent expansion following a strategy of lesion preparation with either a Super High-Pressure NC PTCA Balloon (OPN NC) or a Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty in an angiographically well-defined group of patients with severely calcified coronary lesions (grade 3) undergoing coronary stent implantation (SYNERGY everolimus-eluting stent (EES)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPN NC | Experimental | Device: Super High-Pressure NC PTCA Balloon (OPN NC)Patients receiving a Super High-Pressure NC PTCA Balloon (OPN NC) |
| NSE Alpha | Experimental | Device: Scoring PTCA Balloon (NSE Alpha)Patients receiving a Scoring PTCA Balloon (NSE Alpha) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age above 18 years and consentable;
- Persistent angina symptoms despite optimal medical therapy and/or evidence of inducible ischemia;
- Angiographically-proven coronary artery disease;
- De novo lesion in a native coronary artery;
- Target reference vessel diameter between 2.25 and 4.00 mm by visual estimation;
Key exclusion criteria (6 listed)
- Myocardial infarction (within 1 week);
- Limited long-term prognosis due to other conditions;
- Target lesion is in a coronary artery bypass graft;
- Target lesion is an in-stent restenosis;
- Target lesion is aorto-ostial;
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 |
|---|---|---|
| Super High-Pressure NC PTCA Balloon (OPN NC)Strategy of Super High-Pressure NC PTCA Balloon (OPN NC) after unsuccessful lesion preparation with conventional NC balloon angioplasty. | Device | OPN NC |
| Scoring PTCA Balloon (NSE Alpha)Strategy of Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty. | Device | NSE Alpha |
Primary outcome
Stent expansion index (SEI)
Time frame: intraprocedural
Stent expansion index (SEI), defined as minimum stent area divided by mean reference area in an optical coherence tomography (OCT) quantitative analysis
8 secondary outcomes
Angiographic Success
Time frame: intraprocedural
Procedural Success
Time frame: 30 days
Strategy Success
Time frame: intraprocedural
Acute lumen gain,
Time frame: intraprocedural
Complementary lesion preparations
Time frame: intraprocedural
Rate of vessel perforation
Time frame: intraprocedural
Procedure duration
Time frame: intraprocedural
Contrast volume
Time frame: intraprocedural
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 22 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Robert A Byrne, MD BCh PhD study chair
Deutsches Herzzentrum Muenchen
Salvatore Cassese, MD PhD principal investigator
Deutsches Herzzentrum Muenchen
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super High-Pressure NC PTCA Balloon (OPN NC) and Scoring PTCA Balloon (NSE Alpha) in people with Calcified Coronary Artery Disease (Grade 3), run by Deutsches Herzzentrum Muenchen at 5 sites in 2 countries.
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 8 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: finished, as of the sponsor's last update on 22 Nov 2019. 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 Germany, Switzerland. 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?
Stent expansion index (SEI) (time frame: intraprocedural). 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 22 Nov 2019.