Debulking With Rotational Atherectomy Versus Balloon Angioplasty In

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

This study is to establish the primary hypothesis that debulking with rotational atherectomy (RA) followed by balloon angioplasty (BA) is superior to BA alone for lesion preparation in patients with coronary in-stent restenosis (ISR) regarding angiography-measured in-segment minimal lumen area at 1 year.

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Recruiting	`NCT04414176` - Iran- Premature Coronary Artery Disease
Active, not recruiting	`NCT03394079` - Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention	N/A

NCT number	NCT03401203
Study type	Interventional
Source	Asan Medical Center
Contact
Status	Completed
Phase	N/A
Start date	May 8, 2018
Completion date	December 31, 2022

Debulking With Rotational Atherectomy Versus Balloon Angioplasty In Patients With In-stent Restenosis — ROTA-ISR

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms