Shockwave Coronary Lithoplasty Study

NCT02758379 | Completed

• 1 other identifier: TD 0200
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to study the early safety and feasibility of the Shockwave Coronary Lithoplasty System. To demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, de novo coronary lesions.

Conditions

Coronary Stenosis

Keywords

coronary artery disease; calcified lesions; lithotripsy

Outcome Measures

Primary Outcomes (16)

• Safety - Acute, as indicated by number of subjects that do not experience death following delivery of shockwave energy

  Post-procedure (within 24 hours following procedure)

• Safety - Acute, as indicated by number of subjects that do not experience tamponade following delivery of shockwave energy

  Post-procedure (within 24 hours following procedure)

• Safety - Acute, as indicated by number of subjects that do not experience dissection, occlusion or perforation of the coronary artery that requires additional intervention to treat besides stenting following delivery of shockwave energy

  Post-procedure (within 24 hours following procedure)

• Safety - Acute, as indicated by number of subjects that do not experience aneurysm following delivery of shockwave energy

  Post-procedure (within 24 hours following procedure)

• Safety - Acute, as indicated by number of subjects that do not experience MI (CPK > 5 x uln) following delivery of shockwave energy

  Post-procedure (within 24 hours following procedure)

• Safety - Acute, as indicated by number of subjects that do not experience cardiogenic shock following delivery of shockwave energy

  Post-procedure (within 24 hours following procedure)

• Safety - Acute, as indicated by number of subjects that do not experience distal embolization compromising blood flow, and requiring intervention following delivery of shockwave energy

  Post-procedure (within 24 hours following procedure)

• Safety - Acute, as indicated by number of subjects that do not experience blood transfusion due to excessive blood loss following delivery of shockwave energy

  Post-procedure (within 24 hours following procedure)

• Safety - Acute, as indicated by number of subjects that do not experience stroke following delivery of shockwave energy

  Post-procedure (within 24 hours following procedure)

• Safety - 30 days (Number of subjects without any procedure and/or device related adverse events)

  30 days post procedure

• Safety - 30 days (Number of subjects without target lesion revascularization (TLR)

  30 days post procedure

• Safety - 30 days (Number of subjects without groin complications)

  30 days post procedure

• Safety - 180 days (Number of subjects without any procedure and/or device related adverse events)

  180 days post procedure

• Safety - 180 days (Number of subjects without any target lesion revascularization (TLR))

  180 days post procedure

• Performance - Acute technical success of the device

  * Successful delivery of the device and administration of lithotripsy-enhanced low pressure balloon dilation to the target lesion * Residual stenosis of ≤50% of the reference vessel size of the target lesion assessed by angiography and either IVUS or OCT. * Successful access of the treatment site with a coronary stent

  Post-procedure (within 24 hours following procedure)

• Safety - Acute, as indicated by number of subjects that do not experience ventricular arrhythmic event requiring intervention to re-establish normal rhythm following delivery of shockwave energy

  Post-procedure (within 24 hours following procedure)

Study Arms (1)

Shockwave Coronary Lithoplasty System

EXPERIMENTAL

Patients receive Lithoplasty treatment prior to placement of coronary stent. IVUS or OCT documents patency pre and post Lithoplasty. Patient is followed for patency at discharge, 30 days and 6 months following treatment.

Device: Shockwave Coronary Lithoplasty System

Interventions

Shockwave Coronary Lithoplasty System DEVICE

Lithotripsy shockwaves are used to fracture calcified lesions in the coronary arteries

Shockwave Coronary Lithoplasty System

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age and able to give informed consent.
• Patients in Sinus Rhythm.
• Patients with significant (\> 50% diameter stenosis) native coronary artery disease including stable or unstable angina and silent ischemia, suitable for PCI.
• Ability to tolerate dual antiplatelet agent (i.e. aspirin, clopidogrel or prasugrel). For 1 year and single therapy for life.
• Patient is able and willing to comply with all assessments in the study.
• Stenosis of LAD, RCA or LCX artery ≥50% in a reference vessel of 2.5mm-3.5 mm diameter and ≤ 22 mm length, as assessed by two orthogonal angiographic views.
• Calcification with parallel calcium at least 50% the length of the lesion.
• At the time of the procedure the subject is in Sinus Rhythm.
• Single lesions per vessel.
• Ability to pass a 0.014" guide wire across the lesion.

You may not qualify if:

• Concomitant use of Rotablator, Cutting Balloon, or investigational coronary devices.
• Additional planned coronary interventions for a non-target lesion within 180 days of the study procedure.
• Left ventricular ejection fraction \< 40%
• Patients refusing or not candidates for emergency coronary artery bypass grafting (CABG) surgery
• Uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg)
• Patients who are not candidates for dual anti-platelet therapy for 30 days and chronic single anti-platelet therapy
• Severe renal failure with creatinine \>2.5 mg/dL
• Untreated pre-procedural hemoglobin \<10 g/dL
• Coagulopathy manifested by platelet count \<100,000 or International Normalized ratio (INR) \>1.7 (INR is only required in patients who have taken warfarin within 2 weeks of enrollment)
• Patients in cardiogenic shock
• Acute myocardial infarction (MI) within the past one (1) month, and/or elevated CPK (and abnormal Troponin-I) at the time of enrollment
• Patients with a life expectancy of less than 1 year
• Target main branch vessel \< 2.5 mm in diameter
• Target main branch lesion \> 22 mm in length
• Chronic Total Occlusion (CTO).

Sponsors & Collaborators

• Shockwave Medical, Inc.: lead
• Yale Cardiovascular Research Group: collaborator
• Massachusetts General Hospital: collaborator
• Pacific Clinical Research Group: collaborator

Study Sites (1)

St. Vincent's Hospital Melbourne

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Coronary Stenosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Robert Whitbourn, M.D.

  St. Vincent Hospital, Melbourne, Australia

  PRINCIPAL INVESTIGATOR

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: January 16, 2015
• First Posted: May 2, 2016
• Study Start: July 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

AU (1)