Short-term Perfusion Angiography Pilot Study (SPA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-02-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Short term Perfusion Angiography (SPA) study is designed to collect 2D Perfusion data from Critical Limb Ischemia (CLI) endovascular (interventional) procedures for information on device performance in a real-world setting.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The SIR-POBA Shunt Trial

NCT06056206

Arteriovenous Fistula Stenosis

WITHDRAWN NA

Evaluation of the Effect of the Flowaid Device in Increasing Local Circulation in the Leg

NCT00538226

Peripheral Vascular Disease

COMPLETED PHASE1

Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis

NCT02568293

Peripheral Arterial Disease

UNKNOWN NA

Evaluation of All'InCath in Peripheral Vasculature Percutaneous Transluminal Angioplasty.

NCT05497440

Vascular Diseases

WITHDRAWN NA

Tack Optimized Balloon Angioplasty Post-Market Study

NCT05361967

PAD - Peripheral Arterial Disease PAD Dissection +3 more

TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This clinical study is designed to collect pre and post procedural imaging data using 2D Perfusion (2DP) software in patients receiving an endovascular intervention.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Arterial Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subject is ≥ 18 years of age.
2. Subject or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent
3. Subject has appropriate femoral arterial access
4. Subject presents with a Rutherford classification of 4 to 6.
5. Planned DSA with endovascular intervention below the knee on one or both limbs. This may include patients who undergo:

1. Above the knee (ATK) and below the knee (BTK) intervention during the same procedure.
2. Only BTK intervention.
3. ATK intervention with staged future BTK intervention within 6 weeks of the initial procedure.

Exclusion Criteria

1. Subjects whose ATK intervention is limited to only the common femoral or iliac arteries
2. Subject is unwilling or unable to comply with the protocol including all follow-up visits
3. Subject with active atrial fibrillation at time of procedure
4. Critical limb ischemia due to acute arterial occlusion.
5. Subject with documented ejection fraction \< 40% and/or prolonged bradycardia (\< 60 beats per minute)
6. Inability to collect toe pressure on index limb from subject
7. Subjects with history of or known reaction or sensitivity to contrast agent that cannot be pre-medicated or any other condition that precludes an endovascular intervention and DSA
8. Female subject of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to enrollment), or plans a pregnancy during study period,
9. Subject life expectancy \< 3 months,
10. Subject is participating in a potentially confounding device or drug clinical trial that interferes with this study
11. Investigator considers subject to be a poor candidate for the study or believes that the patient may compromise the study, e.g., concomitant conditions (reasons will be documented) )

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No