## Protocol Section
### Identification Module
**NCT ID:** NCT02974179

**Brief Title:** A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia

**Official Title:** A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia

#### Organization Study ID Info
**ID:** AG-CLI-0206-LTFU
#### Organization
**Class:** INDUSTRY
**Full Name:** AnGes USA, Inc.
#### Secondary ID Infos
**ID:** 2016-003491-41
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2020-01-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-03-12

**Type:** ACTUAL

**Last Update Submit Date:** 2020-03-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-01-10

**Type:** ACTUAL

#### Start Date
**Date:** 2017-02-20

**Type:** ACTUAL

**Status Verified Date:** 2020-03

#### Study First Post Date
**Date:** 2016-11-28
**Type:** ESTIMATED
**Study First Submit Date:** 2016-11-23
**Study First Submit QC Date:** 2016-11-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** AnGes USA, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the AG-CLI-0206-LTFU study

**Detailed Description:** The study is designed to assess the long term safety of subjects who have been treated in the phase 3 study with AMG0001. A health questionnaire will be used to collect specific information from the subject every 6 months. Only those subjects that were randomized in the AG-CLI-0206 study and who received AMG0001 are eligible to participate in this long term follow-up study. Subjects that received placebo will not be eligible for participation in this study.

### Conditions Module

**Conditions:**

- Critical Limb Ischemia

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 9

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects from Study AG-CLI-0206 who received the study product AMG0001

**Intervention Names:**

- Biological: Subjects from Study AG-CLI-0206 who received AMG0001

**Label:** Subjects who received AMG0001

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Subjects who received AMG0001

**Description:** Subjects from Study AG-CLI-0206 who received the study product AMG0001

**Name:** Subjects from Study AG-CLI-0206 who received AMG0001

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** A health questionnaire will be used to collect specific information from the subject every 6 months

**Measure:** Assess the long term safety of subjects from the AG-CLI-0206 study who have been treated with AMG0001

**Time Frame:** 3 years from the date last subject randomized into AG-CLI-0206 study

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subjects who have been treated with AMG0001 in the AG-CLI-0206 study.
* Subjects who have provided consent for this long term follow-up study either directly or through a legally authorized representative.
* Subjects who have provided a release of information to the sponsor.

Exclusion Criteria:

* Subjects who were not enrolled in the AGCLI-0206 study.
* Subjects who enrolled in AG-CLI-0206 and who were not treated with AMG0001.
* Subjects who have not provided consent to this long term follow-up study either directly or through a legally authorized representative.
* Subjects who have not provided a release of information for the Sponsor to contact them directly via phone, email and/or mail.

**Maximum Age:** 90 Years

**Minimum Age:** 40 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Subjects with critical limb ischemia who have previously been treated with AMG0001 in the AG-CLI-0206 study.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lebanon

**Country:** United States

**Facility:** Dartmouth-Hitchcock Medical Center

**State:** New Hampshire

**Zip:** 03756

#### Overall Officials

**Official 1:**

**Affiliation:** Dartmouth-Hitchcock Medical Center

**Name:** Richard Powell, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000058729

- Term: Peripheral Arterial Disease

- ID: D000050197

- Term: Atherosclerosis

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000016491

- Term: Peripheral Vascular Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10543

- Name: Ischemia

- Relevance: HIGH

- As Found: Ischemia

- ID: M2714

- Name: Chronic Limb-Threatening Ischemia

- Relevance: HIGH

- As Found: Critical Limb Ischemia

- ID: M29213

- Name: Peripheral Arterial Disease

- Relevance: LOW

- As Found: Unknown

- ID: M18894

- Name: Peripheral Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26188

- Name: Atherosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000089802

- Term: Chronic Limb-Threatening Ischemia

- ID: D000007511

- Term: Ischemia

### Misc Info Module

- Version Holder: 2024-05-24
