The Indigo System in Acute Lower Limb Malperfusion

Clinical Trial Summary

To evaluate, in a controlled setting, the early safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (San Francisco, California), and to define optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions.

See also
	Status	Clinical Trial	Phase
	Recruiting	`NCT05255640` - OUTCOME OF PATIENTS ADMITTED WITH ACUTE LOWER EXTREMITY ISCHEMIA
	Completed	`NCT02835027` - Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014	N/A

See also

Status

Clinical Trial

Phase

Recruiting

NCT05255640 - OUTCOME OF PATIENTS ADMITTED WITH ACUTE LOWER EXTREMITY ISCHEMIA

Completed

NCT02835027 - Treatment of Acute Lower Limb Ischaemia in Sweden 1994-2014

N/A

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

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.

NCT number	NCT03386370
Study type	Interventional
Source	Azienda Ospedaliera Universitaria Senese
Contact	Gianmarco de Donato, MD
Phone	+390577585123
Email	dedonato@unisi.it
Status	Recruiting
Phase	N/A
Start date	September 1, 2017
Completion date	May 2019

The Indigo System in Acute Lower Limb Malperfusion — INDIAN

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms