Clinical Study Protocol - Debris Interventional Removal in ACS (DESIRE-ACS)

NCT02325869 | Unknown DMC

• 1 other identifier: CP-0013.CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Disease; Acute Coronary Syndrome; Coronary Occlusion

Keywords

Acute Coronary Syndrome, Coronary Occlusion, catheter

Outcome Measures

Primary Outcomes (3)

• 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)

  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

  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

  During procedure and up to 30 (+/-7) days post procedure

Study Arms (1)

Bell Balloon Catheter

EXPERIMENTAL

The Bell Balloon Catheter is designed to help the physician capture some of this material that may have broken off.

Device: Bell Balloon Catheter

Interventions

Bell Balloon Catheter DEVICE

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 Upon deflation, debris from the blockage is withdrawn into the cavity formed between the deflated balloon and its outer capsule.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.

Bell Balloon Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• Subject not capable of understanding and signing the Informed Consent form.

Sponsors & Collaborators

• Angioslide Ltd.: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

RECRUITING

MeSH Terms

Conditions

Coronary Disease; Acute Coronary Syndrome; Coronary Occlusion

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Giora Weisz, Prof. M.D

  Chairman, Department of Cardiology. Shaare Zedek Medical Center, Jerusalem Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eran Vickus

CONTACT

+972 9 7904609; eranv@angioslide.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 25, 2014
• Study Start: July 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

IL (1)