Rotablation vs Intravascular Lithotripsy in Calcified Coronary Lesions

NCT04960319 | Unknown DMC FDA Device

• 1 other identifier: DECALCIFY
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective, 1:1 randomized, controlled, multicenter trial to assess effectiveness and safety of Intravascular Lithotripsy (IVL) compared to Rotational Atherectomy (RA) treatment in calcified coronary lesions

Conditions

Coronary Artery Disease; Calcification

Keywords

Intravascular Lithotripsy; Rotational Atherectomy

Outcome Measures

Primary Outcomes (2)

• Percent of stent expansion evaluated by Optical Coherence Tomography assessed by core lab.

  Primary Effectiveness endpoint

  at the end of the intervention

• Rate of in-hospital MACCE

  primary Safety endpoint

  72 hours

Secondary Outcomes (2)

• Percentage of mean stent expansion evaluated by optical coherence tomography as assessed by core lab.

  at the end of the intervention

• Rate of peri-procedural myocardial injury ,Peri-procedural myocardial infarction, Slow flow/no-reflow

  72 hours

Study Arms (2)

Intravascular Lithotripsy

EXPERIMENTAL

Study Device Treatment: IVL balloon catheter size is chosen in a 1:1 ratio to the distal reference vessel diameter. If the IVL balloon cannot be delivered into the target lesion a Guide catheter extension is recommended. The balloon catheter is then inflated to 4 ATM and 10 impulses are delivered. The balloon is then inflated to 6 ATM and deflated to reestablish blood flow. Up to 80 impulses can subsequently be delivered and the balloon can be repositioned within the lesion. In multiple lesions with different reference vessel diameters different sizes of IVL balloon can be used.

Device: Intravascular Lithotripsy

Rotational Atherectomy

ACTIVE COMPARATOR

Control group treatment: Rotablation should be performed as described in the ESC-Consensus document. Burr/vessel-ratio is 0.5 - 0.75. The use of different burr sizes as well as the use of a temporary pacemaker is left to the operator's discretion.

Device: Intravascular Lithotripsy

Interventions

Intravascular Lithotripsy DEVICE

Coronary Angiography. When the anatomic inclusion criteria are met, traverse the lesion with a guidewire. If traversal fails, assign the subject to the registry. After wire traversal has been documented by cine angiography, angiographic, OCT-defined or balloon expansion criteria are met, subject is enrolled. Blood sample for Troponin (hs TnT) baseline measurement has to be taken. The subjects will be randomized in a 1:1 fashion to treatment with either IVL or RA.

Intravascular Lithotripsy; Rotational Atherectomy

Eligibility Criteria

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

You may qualify if:

• Subject age ≥ 18 years
• Subject has been informed of the nature of the study, agrees to participate and has signed a Medical Ethics Committee approved consent form, understands the duration of the study, agrees to attend follow-up visits
• LVEF \>25%
• Single de-novo target lesion with stenosis ≥ 70% and \< 100% or ≥ 50% and \< 70% with evidence of ischemia, or FFR ≤ 0.80, or lumen area ≤ 4.0 mm2 (≤ by 6.0mm2 in left main) IVUS or OCT
• Target vessel RVD ≥ 2.5 mm and ≤4.0 mm
• Lesion length ≤ 60 mm
• Lesion site severe calcification: Angiographic radio-opacities prior to contrast involving both sides of arterial wall with total calcium length ≥10 mm, or presence of ≥270° of calcium on at least one cross section by IVUS or OCT or incomplete balloon expansion at 12 atm
• Target lesion was traversed by a guide wire

You may not qualify if:

• Failure to successfully cross the target lesion with the guidewire
• Target lesion in a coronary artery bypass graft
• In-stent-Restenosis
• Thrombus in the target vessel
• Chronic total occlusion in the target vessel
• ST-elevation myocardial infarction (STEMI) within the last 4 weeks prior to enrollment
• Stroke within the last 3 months prior to enrollment
• Decompensated heart failure
• Life expectancy of less than one year
• Chronic kidney disease (serum creatinine \> 2.5mg/dl)
• Pregnant or lactating females
• Receiving dialysis or immunosuppressant therapy
• Platelet Count \< 100.000mm3 or \> 600.000mm3
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of antiplatelet therapy
• Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies or contrast media that cannot be adequately pre-treated prior to index procedure

Sponsors & Collaborators

• Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.: lead
• Shockwave Medical, Inc.: collaborator
• Asklepios proresearch: collaborator

MeSH Terms

Conditions

Coronary Artery Disease; Calcinosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Joachim Schofer, MD, PhD

  Medical Care Center Prof. Mathey, Prof. Schofer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joachim Schofer, MD, PhD

CONTACT

+4940889009889; schofer@herz-hh.de

Christina Brinkmann, MD

CONTACT

+4940889009889; c.brinkmann@herz-hh.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Core Lab is blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, 1:1 randomized, controlled, multicenter trial to assess effectiveness and safety of Intravascular Lithotripsy (IVL) compared to Rotational Atherectomy (RA) treatment in calcified coronary lesions. An interim analysis after enrollment of 50 patients randomized will be performed. Based on the result the sample size will be calculated.

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 13, 2021
• Study Start: January 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: June 1, 2024
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: at the time of publication