NCT03108456: ECLIPSE

Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts: The ECLIPSE Trial

Status unknown NA Last updated 6 October 2023

What this trial tests

NA trial testing Orbital Atherectomy in Coronary Artery Disease in 2,005 participants. Status unknown.

Timeline

27 March 2017

Primary endpoint
12 June 2024

12 June 2025

Quick facts

Lead sponsor	Abbott Medical Devices
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	2,005
Start date	27 March 2017
Primary completion	12 June 2024
Estimated completion	12 June 2025
Sites	104 locations across United States

Drugs / interventions tested

• Orbital Atherectomy
• Balloon

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Ischemic Heart Disease — all drugs for Ischemic Heart Disease →
• Non ST Segment Elevation Myocardial Infarction — all drugs for Non ST Segment Elevation Myocardial Infarction →

Sponsor

Abbott Medical Devices — full company profile →

Who can join

18 and older, any sex, with Coronary Artery Disease or Ischemic Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions.
   Riley RF, Patel MP, Abbott JD, Bangalore S, et al · · 2024 · cited 58× · PMID 39132214 · DOI 10.1016/j.jscai.2023.101259
2. Contemporary Approach to Heavily Calcified Coronary Lesions.
   Sorini Dini C, Nardi G, Ristalli F, Mattesini A, et al · · 2019 · cited 57× · PMID 31867062 · DOI 10.15420/icr.2019.19.r1
3. Contemporary percutaneous management of coronary calcification: current status and future directions.
   Hennessey B, Pareek N, Macaya F, Yeoh J, et al · · 2023 · cited 24× · PMID 36796870 · DOI 10.1136/openhrt-2022-002182
4. Novel Micro Crown Orbital Atherectomy for Severe Lesion Calcification: Coronary Orbital Atherectomy System Study (COAST).
   Redfors B, Sharma SK, Saito S, Kini AS, et al · · 2020 · cited 21× · PMID 32757661 · DOI 10.1161/circinterventions.120.008993
5. Randomized evaluation of vessel preparation with orbital atherectomy prior to drug-eluting stent implantation in severely calcified coronary artery lesions: Design and rationale of the ECLIPSE trial.
   Généreux P, Kirtane AJ, Kandzari DE, Armstrong EJ, et al · · 2022 · cited 20× · PMID 35288105 · DOI 10.1016/j.ahj.2022.03.003
6. Contemporary Management of Severely Calcified Coronary Lesions.
   Angsubhakorn N, Kang N, Fearon C, Techorueangwiwat C, et al · · 2022 · cited 19× · PMID 36294777 · DOI 10.3390/jpm12101638
7. Lesion Preparation with Orbital Atherectomy.
   Shlofmitz E, Jeremias A, Shlofmitz R, Ali ZA. · · 2019 · cited 16× · PMID 31867064 · DOI 10.15420/icr.2019.20.r1
8. Atherectomy Techniques: Rotablation, Orbital and Laser.
   Khattak S, Sharma H, Khan SQ. · · 2024 · cited 9× · PMID 39569386 · DOI 10.15420/icr.2024.16