Coronary DiseaseDESIRE-ACSNCT02325869
Clinical Study Protocol - Debris Interventional Removal in ACS (DESIRE-ACS)
A study testing Bell Balloon Catheter in people with Coronary Disease and Acute Coronary Syndrome, run by Angioslide Ltd. at 1 site in Israel.
Trial summary
DebriS Interventional REmoval in ACS (DESIRE-ACS) Study to assess the safety and performance of the ECA Bell balloon in subjects undergoing coronary percutaneous interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Acute Coronary Syndrome, Coronary Occlusion
- What is being tested?
- Bell Balloon Catheter
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2015to Mar 2016
- 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
- Clinical criteria
- Subject is ≥18 years of age.
- Subject with acute coronary syndrome (STEMI or NSTEMI).
- Candidate for percutaneous coronary intervention (PCI) in native coronary artery.
- Anticipated patient life expectancy of at least 1 year since enrollment.
- Subject is male or a non-pregnant female.
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- Subject has provided written informed consent.
- Subject is able and willing to adhere to the required follow-up visits and testing.
- Angiographic Criteria
- Lesions amendable to PCI.
- Angiographically thrombotic-appearing lesion that amenable to PCI.
- Lesion(s) is located within the native vessel and has ≥ 50% but <100% stenosis.
- The target lesion should be at least 10mm proximal to the proximal edge of a stented lesion.
- Only a single lesion will be treated by the investigational device.
- Vessel has thrombolysis in myocardial infarction (TIMI) grade 1 or higher flow before the use of the investigational device.
- Reference vessel diameter, where the Bell balloon is to be placed, is 3-4mm in diameter by angiographic visual estimation.
Who cannot join
- Clinical Criteria
- Women except those whose menstrual periods have not occurred for more than one year after menopause or those who have had sterilization surgery (tubal ligation) or hysterectomy
- Known contraindication to the use of heparin or bivalirum (Angiomax).
- Known contraindication to the use of dual anti-platelet therapy
- Known hypersensitivity to contrast media which cannot be adequately pretreated.
- Subject has renal insufficiency, defined as baseline creatinine level ≥ 2.0 mg/dl.
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- Subject has a known history of neutropenia (WBC <3,000/mm3) or significant anemia.
- Subjects has a known history of coagulopathy or thrombophilia [prothrombin International Normalized Ratio (INR)>1.5, Platelet count<80,000/ μL], that has not resolved or has required treatment in the past 6 months.
- Major bleeding within 6 months of index procedure.
- A planned invasive surgical procedure within 30 days.
- Undergone cardiac surgery within the past 30 days or has a planned surgical procedure within 30 days from study procedure
- Left ventricular ejection fraction < 25%
- The patient is in cardiogenic shock or hemodynamic unstable
- Cerebrovascular Accident (CVA) or TIA within the past 6 months.
- Exclusions that preclude placement of the bell balloon per the Instruction for Use
- Subject not capable of understanding and signing the Informed Consent form.
- Angiographic Criteria
- Anatomical exclusions that preclude placement of the bell balloon per the Instruction for Use.
- Target lesion inside or within 10mm of a prior stent
- Target lesion distal to a prior placed stent
- Severe calcification at the lesion site or proximal to it.
- Aorto-ostial lesions
- Bifurcation lesions (side branch diameter ≥ 2.0mm)
- Severe coronary artery tortuosity (Angulation >450)
- Target lesion is totally occluded, or Thrombolysis in Acute MI (TIMI flow 0) despite pre-dilatation with small caliber balloon
- Coronary artery spasm in the absence of a significant stenosis
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
Giora Weisz, Prof., MD, 972.2.6555.975, cardio@szmc.org.il
About this study
Official title: DebriS Interventional REmoval in ACS (DESIRE-ACS) Study to Assess the Safety and Performance of the ECA Bell Balloon in Subjects Undergoing Coronary Percutaneous Interventions.
DebriS Interventional REmoval in ACS (DESIRE-ACS) Study to assess the safety and performance of the ECA Bell balloon in subjects undergoing coronary percutaneous interventions.
Read the detailed description
Coronary arterial disease (CAD) is defined as obstruction of blood flow into the coronary arteries (i.e. the arteries that supply blood to the heart muscle). Patients with symptoms of coronary artery disease usually suffer from stable angina pectoris (chest pain or discomfort), unstable angina pectoris, or a myocardial infarction (heart attack). The symptoms range from mild angina, to moderate or severe angina.
In some cases of CAD the blood vessel is chronically totally blocked (total occlusion), stopping blood flow through the blocked blood vessel. In these cases a minimally invasive treatment or a surgery may be needed. "Minimally invasive procedures" consist of angioplasty or stent placement. The procedure is performed under local anesthetic with the patient lying on their back.
Angioplasty is a routine, well known, non-surgical procedure that is performed by making a small incision of the skin in the groin through which a catheter (narrow tube) and a guidewire (a thin metal wire) are inserted to reach the blocked artery. After reaching the blocked artery and crossing the blockage with a guidewire, a tiny balloon is inflated inside the artery to open the blockage. During the course of this procedure small pieces of the material that is causing the blockage may break off and be carried by the blood stream to other parts of the body where they may lodge and cause damage by blocking the blood flow . The Bell Balloon Catheter is designed to help the physician capture some of this material that may have broken off.
- Being tested
- Bell Balloon Catheter
- Keywords
- Acute Coronary Syndrome, Coronary Occlusion, catheter
- Medical subject headings
- Coronary Disease, Acute Coronary Syndrome, Coronary Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bell Balloon CatheterDevice
An angioplasty procedure to open the blockage in blood vessels will be performed. Standard angioplasty procedure includes local analgesia of the groin area and a small cut through which the procedure will be performed. An introducer sheath (thin tube) will be inserted. The Bell Balloon dilatation will then be inserted. The Bell Balloon works in fashion similar to standard balloon with the same physical and behavioral characteristics. Upon deflation, debris from the blockage is withdrawn into the cavity formed between the deflated balloon and its outer capsule. Then balloon is retracted and retrieved through the guiding catheter, together with the captured debris and trap it between the outer surface of the balloon and the inner surface of the membrane.
| Study group | Role | What they receive |
|---|---|---|
| Bell Balloon Catheter | Experimental | The Bell Balloon Catheter is designed to help the physician capture some of this material that may have broken off. Receives: Device: Bell Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of major adverse cardiac events (MACE)
Defined as a composite of cardiac death, all myocardial infarction (Q wave and non-Q wave), and target lesion revascularization (PCI and CABG)
Measured: Up to 30 (+/-7) days post procedure
Angiographic and Device Success
Defined as patent vessel with stenosis <50% with a final TIMI flow grade 3 (visually assessed by angiography) without side branch loss, flow-limiting dissection, or angiographic thrombus and embolic material retrieval.
- Thrombolysis In Myocardial Infarction (TIMI) flow grade at the end of the revascularization procedure, compared to baseline.
- ST resolution level in patients with ST-Elevation Myocardial Infarction (STEMI).
- Myocardial Blush Grade (MBG) at the end of procedure, compared to baseline
Measured: During procedure and up to 30 (+/-7) days post procedure
Performance - Device success
Defined as ability to deliver, deploy, and intact retract retrieval of the study device and retrieve embolic material
Measured: During procedure and up to 30 (+/-7) days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startJul 2015
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angioslide Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giora Weisz, Prof. M.D, Principal investigator, Chairman, Department of Cardiology. Shaare Zedek Medical Center, Jerusalem Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325869
- Sponsor's protocol ID
- CP-0013.CTIL
- Acronym
- DESIRE-ACS
- Status last verified
- Jul 2015
- First submitted
- 22 Dec 2014
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DebriS Interventional REmoval in ACS (DESIRE-ACS) Study to Assess the Safety and Performance of the ECA Bell Balloon in Subjects Undergoing Coronary Percutaneous Interventions.
- ClinicalTrials.gov ID
- NCT02325869
- Acronym / sponsor ID
- DESIRE-ACS / CP-0013.CTIL
- Keywords
- Acute Coronary Syndrome, Coronary Occlusion, catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Angioslide Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 25 Dec 2014 (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.
DebriS Interventional REmoval in ACS (DESIRE-ACS) Study to assess the safety and performance of the ECA Bell balloon in subjects undergoing coronary percutaneous interventions.
Detailed description
Coronary arterial disease (CAD) is defined as obstruction of blood flow into the coronary arteries (i.e. the arteries that supply blood to the heart muscle). Patients with symptoms of coronary artery disease usually suffer from stable angina pectoris (chest pain or discomfort), unstable angina pectoris, or a myocardial infarction (heart attack). The symptoms range from mild angina, to moderate or severe angina.
In some cases of CAD the blood vessel is chronically totally blocked (total occlusion), stopping blood flow through the blocked blood vessel. In these cases a minimally invasive treatment or a surgery may be needed. "Minimally invasive procedures" consist of angioplasty or stent placement. The procedure is performed under local anesthetic with the patient lying on their back.
Angioplasty is a routine, well known, non-surgical procedure that is performed by making a small incision of the skin in the groin through which a catheter (narrow tube) and a guidewire (a thin metal wire) are inserted to reach the blocked artery. After reaching the blocked artery and crossing the blockage with a guidewire, a tiny balloon is inflated inside the artery to open the blockage. During the course of this procedure small pieces of the material that is causing the blockage may break off and be carried by the blood stream to other parts of the body where they may lodge and cause damage by blocking the blood flow . The Bell Balloon Catheter is designed to help the physician capture some of this material that may have broken off.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bell Balloon Catheter | Experimental | Device: Bell Balloon CatheterThe Bell Balloon Catheter is designed to help the physician capture some of this material that may have broken off. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Clinical criteria
- Subject is ≥18 years of age.
- Subject with acute coronary syndrome (STEMI or NSTEMI).
- Candidate for percutaneous coronary intervention (PCI) in native coronary artery.
- Anticipated patient life expectancy of at least 1 year since enrollment.
Key exclusion criteria (26 listed)
- Clinical Criteria
- Women except those whose menstrual periods have not occurred for more than one year after menopause or those who have had sterilization surgery (tubal ligation) or hysterectomy
- Known contraindication to the use of heparin or bivalirum (Angiomax).
- Known contraindication to the use of dual anti-platelet therapy
- Known hypersensitivity to contrast media which cannot be adequately pretreated.
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 |
|---|---|---|
| Bell Balloon CatheterAn angioplasty procedure to open the blockage in blood vessels will be performed. Standard angioplasty procedure includes local analgesia of the groin area and a small cut through which the procedure will be performed. An introducer sheath (thin tube) will be inserted. The Bell Balloon dilatation will then be inserted. The Bell Balloon works in fashion similar to standard balloon with the same physical and behavioral characteristics. Upon deflation, debris from the blockage is withdrawn into the cavity formed between the deflated balloon and its outer capsule. Then balloon is retracted and retrieved through the guiding catheter, together with the captured debris and trap it between the outer surface of the balloon and the inner surface of the membrane. | Device | Bell Balloon Catheter |
Primary outcome
The rate of major adverse cardiac events (MACE)
Time frame: Up to 30 (+/-7) days post procedure
Defined as a composite of cardiac death, all myocardial infarction (Q wave and non-Q wave), and target lesion revascularization (PCI and CABG)
Angiographic and Device Success
Time frame: During procedure and up to 30 (+/-7) days post procedure
Defined as patent vessel with stenosis <50% with a final TIMI flow grade 3 (visually assessed by angiography) without side branch loss, flow-limiting dissection, or angiographic thrombus and embolic material retrieval. * Thrombolysis In Myocardial Infarction (TIMI) flow grade at the end of the revascularization procedure, compared to baseline. * ST resolution level in patients with ST-Elevation Myocardial Infarction (STEMI). * Myocardial Blush Grade (MBG) at the end of procedure, compared to baseline
Performance - Device success
Time frame: During procedure and up to 30 (+/-7) days post procedure
Defined as ability to deliver, deploy, and intact retract retrieval of the study device and retrieve embolic material
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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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.
Giora Weisz, Prof. M.D principal investigator
Chairman, Department of Cardiology. Shaare Zedek Medical Center, Jerusalem Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bell Balloon Catheter in people with Coronary Disease and Acute Coronary Syndrome, run by Angioslide Ltd. at 1 site in Israel.
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 16 inclusion and 26 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 28 Jul 2015. 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 Israel. 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 Eran Vickus (+972 9 7904609, eranv@angioslide.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of major adverse cardiac events (MACE) (time frame: Up to 30 (+/-7) days post procedure). 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?
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 28 Jul 2015.