Shockwave IVL + DCB

Overview

Drug-eluting stent (DES) implantation as interventional strategy for lesions in small coronary arteries is the current standard of care in many centers worldwide, but is associated with increased risk of late treatment failure in small vessels, as compared with larger coronary arteries. Randomized and observational studies have been shown that coronary intervention with drug-coated balloons (DCB) provide a promising alternative to DES implantation in small vessels, while avoiding the risk of a permanent vascular implant. Furthermore, lesions in small vessels are frequently concomitant with diffuse disease and/or distal location, where the presence of calcification is an additional common feature. Intravascular lithotripsy (IVL) has been recently introduced as a novel adjunctive technology to treat calcified lesions. This study will explore the hypothesis that IVL has the potential to enhance the results of coronary balloon dilatation of small vessels with calcified lesions, therefore increasing the likelihood of optimal DBC intervention.

Full Title of Study: “Intravascular Lithotripsy Plus Drug-coated Balloon in Calcified Small Coronary Vessels: a Feasibility Exploratory Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2023

Clinical Trial Outcome Measures

Primary Measures

  • Successful IVL plus DCB
    • Time Frame: at 1 month follow-up
    • Successful IVL plus DCB in the absence of target lesion failure (TLF)

Participating in This Clinical Trial

Inclusion Criteria

1. Age 18 years or older 2. Coronary artery disease with percutaneous intervention clinically indicated to treat one or more lesions fulfilling all criteria below:

  • De novo lesion with diameter stenosis > 50% (visual analysis) – Coronary vessel diameter < 3.0 mm (visual analysis) – Severe calcification at the target segment, defined as fluoroscopic radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least 1 location OR Intravascular Ultrasound/Optical Coherence Tomography (IVUS/OCT) demonstrated calcium angle of ≥270° on at least 1 cross section. 3. Written informed consent Exclusion Criteria:

1. Previous coronary intervention at or < 10 mm distant from target segment at any time. 2. Lesion length ≥ 40 mm. 3. Planned atherectomy or cutting/scoring balloon use. 4. Bifurcation lesion. 5. Thrombus containing lesion. 6. Life expectancy < 12 months due to other co-morbid condition(s) that could limit patient's ability to participate in clinical study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rede Optimus Hospitalar SA
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Flavio Ribichini, MD, Principal Investigator, Universita di Verona
    • Pedro Lemos, MD, Principal Investigator, Hospital Israelita Albert Einstein, São Paulo
  • Overall Contact(s)
    • Annelena Held-Wehmöller, PhD, +4915785128140, info@fcre.eu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.